
Search Clinical Trials
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User-friendliness of a Portable Driving Simulator
University of Kansas Medical Center
Parkinson Disease
Multiple Sclerosis
Stroke
The use of simulators to retrain driving skills of patients with stroke, Parkinson's
disease (PD), or multiple sclerosis (MS) is very limited because of cost, space required,
and incidence of simulator sickness in high fidelity simulators. The Principal
investigator recently developed a low cost lo1 expand
The use of simulators to retrain driving skills of patients with stroke, Parkinson's disease (PD), or multiple sclerosis (MS) is very limited because of cost, space required, and incidence of simulator sickness in high fidelity simulators. The Principal investigator recently developed a low cost low fidelity portable driving simulator (PDS). In this pilot study, the study team will (1) determine the ease of use and occurrence of simulator sickness while operating the low fidelity PDS in a clinic setting and (2) the efficacy of the low fidelity PDS to reproduce the benefits from retraining impaired driving skills of stroke survivors in a high-fidelity simulator. Participants: 30 participants, separated according to neurological condition including stroke, PD, or MS, will be randomly allocated to either the PDS or fixed-base high-fidelity simulator training. Each participant will undergo a pre-training evaluation, five hours of designated training and a post-training assessment, similar to the pre-training evaluation. Data will be analyzed according to study aims. The investigators hypothesize that the simple set up of the PDS will make it easier to use and better decrease the incidence of simulator sickness that typically leads to stopping therapy than the high-fidelity simulator. The investigators hypothesize that improvements in lane maintenance, adherence to speed limits, reaction to traffic lights, and overall reaction time after training using the PDS will not be significantly different from improvements observed after training using the high-fidelity driving simulator. Type: Interventional Start Date: Aug 2019 |
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Stimulant vs. Non-stimulant Treatments and Reward Processing in Drug-naive Youth at SUD Risk
Icahn School of Medicine at Mount Sinai
ADHD
Attention Deficit Hyperactivity Disorder
The study team will examine the effects of FDA approved stimulant and non-stimulant
medications for ADHD, among youth with ADHD and with and without Oppositional Defiant
Disorder (ODD) or Conduct Disorder (CD), on reward systems of the brain using fMRI. expand
The study team will examine the effects of FDA approved stimulant and non-stimulant medications for ADHD, among youth with ADHD and with and without Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD), on reward systems of the brain using fMRI. Type: Interventional Start Date: Jun 2019 |
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International Rapid-onset Obesity with Hypothalamic Dysfunction, Hypoventilation & Autonomic Dysreg1
Debra Weese-Mayer
ROHHAD
Rapid-Onset Obesity with Hypothalamic Dysfunction, Hypoventilation & Autonomic Dysregulation
The Center for Autonomic Medicine in Pediatrics (CAMP) has collaborated with doctors from
around the world to build the first International ROHHAD (Rapid-onset Obesity with
Hypothalamic Dysfunction, Hypoventilation and Autonomic Dysregulation) REDCap (Research
Electronic Data Capture) Registry. Thi1 expand
The Center for Autonomic Medicine in Pediatrics (CAMP) has collaborated with doctors from around the world to build the first International ROHHAD (Rapid-onset Obesity with Hypothalamic Dysfunction, Hypoventilation and Autonomic Dysregulation) REDCap (Research Electronic Data Capture) Registry. This registry is an international collaboration with ROHHAD patients and their physicians recruited from around the world. The purpose of this IRB-approved research study is to gain a better understanding of the various health problems ROHHAD patients face with advancing age, and how these relate to each patient's specific medical course. With a better understanding of specific ROHHAD and associated clinical manifestations, we will be able to better anticipate healthcare needs and to provide more accurate guidelines to healthcare providers world-wide in caring for patients with ROHHAD. The study aims to obtain detailed phenotypic information (information about health and well-being) on patients with ROHHAD. Participation would require filling out a confidential survey that asks questions regarding health and past medical history. Involvement in the project is completely voluntary and there is no compensation for taking part. However, this project will help us learn more about this devastating disease, with the goal of advancing treatment. Type: Observational [Patient Registry] Start Date: Jun 2013 |
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International Congenital Central Hypoventilation Syndrome (CCHS) Registry and CCHS SHARE
Debra Weese-Mayer
Congenital Central Hypoventilation Syndrome
The Center for Autonomic Medicine in Pediatrics (CAMP), in collaboration with leading
CCHS clinicians, scientists, and patient advocacy groups around the world has built the
first International CCHS (Congenital Central Hypoventilation Syndrome REDCap (Research
Electronic Data Capture) Registry. Thi1 expand
The Center for Autonomic Medicine in Pediatrics (CAMP), in collaboration with leading CCHS clinicians, scientists, and patient advocacy groups around the world has built the first International CCHS (Congenital Central Hypoventilation Syndrome REDCap (Research Electronic Data Capture) Registry. This registry is an international collaboration to capture CCHS natural history data with CCHS patients and their physicians recruited from around the world. This registry is part of a CCHS natural history study that includes the CCHS Secure Health-hub Advancing Research Efforts (CCHS-SHARE), a natural history data platform shared with the broader CCHS research and patient community to house extensive longitudinal, de-identified data. Inclusion of registry data in CCHS-SHARE is optional. The purpose of this IRB-approved research study is to gain a better understanding of the natural history of CCHS, including the various clinical manifestations of CCHS with advancing age, and as related to each patient's specific PHOX2B mutation. With a better understanding of CCHS natural history, we will be able to better anticipate healthcare needs and to provide more accurate guidelines to healthcare providers world-wide in caring for patients with CCHS. The study aims to obtain detailed phenotypic information (information about health and well-being) on patients with CCHS and their families. Participation would require filling out a confidential survey that asks questions regarding phenotype and past medical history. Involvement in the project is completely voluntary and there is no compensation for taking part. However, this project will help us learn more about this disease, with the goal of advancing treatment. Type: Observational [Patient Registry] Start Date: Jun 2013 |
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A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
Beth Israel Deaconess Medical Center
Renal Cell Carcinoma
CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very
accurately to a tumor. The ability of this technology to minimize radiation dose to
organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus
potentially increasing the efficacy of radiat1 expand
CyberKnife Based Radiosurgery is a way to deliver large doses of radiation very accurately to a tumor. The ability of this technology to minimize radiation dose to organs adjacent to the target tumor allows a high dose to be delivered to the tumor, thus potentially increasing the efficacy of radiation treatment. Currently, radiosurgery is commonly used for brain metastases, Stage I lung cancer, spine tumors, and localized prostate cancer. The purpose of this protocol is to evaluate the role of Radiosurgery for the treatment of clinically localized primary renal cell carcinoma. Type: Interventional Start Date: Jul 2013 |
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Molecular Analysis of Samples From Patients With Diffuse Intrinsic Pontine Glioma and Brainstem Gli1
Children's National Research Institute
Diffuse Intrinsic Pontine Glioma
Brainstem Glioma
The purpose of this study is to prospectively collect specimens from pediatric patients
with diffuse intrinsic pontine glioma or brainstem glioma, either during therapy or at
autopsy, in order to characterize the molecular abnormalities of this tumor. expand
The purpose of this study is to prospectively collect specimens from pediatric patients with diffuse intrinsic pontine glioma or brainstem glioma, either during therapy or at autopsy, in order to characterize the molecular abnormalities of this tumor. Type: Observational Start Date: Apr 2010 |
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Collecting and Storing Tissue Samples From Women With or Without Breast Cancer
Vanderbilt-Ingram Cancer Center
Breast Cancer
RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with
or without breast cancer to study in the laboratory may help the study of cancer.
PURPOSE: This research study is collecting and storing tissue samples from women with or
without breast cancer. expand
RATIONALE: Collecting and storing samples of tissue, blood, and urine from patients with or without breast cancer to study in the laboratory may help the study of cancer. PURPOSE: This research study is collecting and storing tissue samples from women with or without breast cancer. Type: Observational Start Date: Jan 2004 |
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Novel Glaucoma Diagnostics
Wills Eye
Glaucoma
Macular Disease
The purpose of this research is to evaluate novel technologies for the assessment of
ocular structure and function, including the scanning device called Optical Coherence
Tomography (OCT). We will test the OCT and other devices in their ability to image
diseases of the eye and also compare the meas1 expand
The purpose of this research is to evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called Optical Coherence Tomography (OCT). We will test the OCT and other devices in their ability to image diseases of the eye and also compare the measurements made with OCT to those of other imaging and visual field devices approved by the Food and Drug Administration (FDA). OCT may be useful for the early diagnosis and monitoring of a variety of types of eye diseases Type: Observational Start Date: Aug 2000 |
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Pain After Buffered Vs Non Buffered Articaine
Cleveland Dental Institute
Pain
Pain after buffered versus non buffered articaine. expand
Pain after buffered versus non buffered articaine. Type: Interventional Start Date: Jan 2024 |
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Opioid Prescribing Practices in Laparoscopic Gynecologic Surgery
University of Tennessee
Opioid Use
Postoperative Pain
The purpose of this study is to compare opioid prescribing practices by either routine
provider prescribing practices, or with the use of a calculator, i.e., the Opioid
Calculator, published by the University of Michigan (www.opioidcalculator.org), with the
intent of decreasing the number of pills. expand
The purpose of this study is to compare opioid prescribing practices by either routine provider prescribing practices, or with the use of a calculator, i.e., the Opioid Calculator, published by the University of Michigan (www.opioidcalculator.org), with the intent of decreasing the number of pills. Type: Interventional Start Date: Jul 2024 |
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Postoperative Pain After Activation of Irrigant
Cleveland Dental Institute
Pain
The purpose of this research is to analyze the levels of pain after cleaning and shaping
in individuals who are receiving root canal therapy using the IVAC irrigation approach,
and those who are treated with ultrasonic irrigation techniques, negative pressure
irrigation technique and traditional ir1 expand
The purpose of this research is to analyze the levels of pain after cleaning and shaping in individuals who are receiving root canal therapy using the IVAC irrigation approach, and those who are treated with ultrasonic irrigation techniques, negative pressure irrigation technique and traditional irrigation techniques. PICOTS Question: Does the new Dent's iVac irrigation protocol has an effect on reduction of postoperative pain By enlisting at least 84 suitable individuals who are undergoing the identical endodontic procedure. pain will be measures by assessing pain levels through a standardized numerical rate scale (NRS) at certain time intervals after root canal treatment, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours. Type: Interventional Start Date: Aug 2023 |
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Impact of Direct Current Electrical Stimulation on Treatment of Lumbosacral Radiculopathy
NeuFit - Neurological Fitness and Education
Radiculopathy Lumbar
Radiculopathy Sacral
Radiculopathy Multiple Sites
This study will compare two methods of electrical stimulation (alternating current and
direct current) as an adjunctive therapy to treating lumbosacral radiculopathy. Both
types of electrical stimulation have been used in clinical practice for physical therapy,
however direct current stimulation is1 expand
This study will compare two methods of electrical stimulation (alternating current and direct current) as an adjunctive therapy to treating lumbosacral radiculopathy. Both types of electrical stimulation have been used in clinical practice for physical therapy, however direct current stimulation is much less common and there is less known about its impact on physical therapy outcomes. The aim of this project is to show the efficacy of a novel device, the Neubie direct current device, compared to traditional TENS unit in clinical physical therapy treatment of radiculopathy. Outcomes measured will include: pain intensity, functional status, neurological status, electrophysiological changes and patient satisfaction. Type: Interventional Start Date: Apr 2024 |
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A Strength-Based Intervention to Improve Job Interview Skills in Young Adults in a Community Setting
Kessler Foundation
Autism Spectrum Disorder
The investigators are looking to evaluate how effective a strength-based intervention may
be in improving job interview skills in young adults. The investigators are examining the
effects of this intervention in young adults who may have difficulty with job interviews,
and who may want to improve t1 expand
The investigators are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. The investigators are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills. Type: Interventional Start Date: Jul 2024 |
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Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN )
Wake Forest University
Hypertension
Cardiovascular Diseases
Diabetes
Nitric Oxide (NO) is an important molecule that is produced naturally in the body and
that helps maintain healthy blood flow. Low availability of NO contributes to many
diseases while administration of NO is therapeutic.
In addition to being made naturally in the body, NO can be obtained through t1 expand
Nitric Oxide (NO) is an important molecule that is produced naturally in the body and that helps maintain healthy blood flow. Low availability of NO contributes to many diseases while administration of NO is therapeutic. In addition to being made naturally in the body, NO can be obtained through the diet via the Nitrate-Nitrite-NO cycle. Nitrate, which is abundant in green leafy vegetables and beetroot juice, is partially converted to nitrite by oral bacteria. The nitrate and nitrite are taken up into the blood and nitrite is converted into NO. Remaining nitrate in the blood is taken back up into the mouth by salivary glands and the cycle continues. Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies where dietary nitrate is given to increase NO and treat various conditions. The current study rests on the premise that the quality of the oral microbiome plays a major role in the Nitrate-Nitrite-NO cycle and hence cardiovascular health and the efficacy of dietary nitrate interventions. Investigators have begun to identify oral bacterial species that are effective nitrite producers as well as though that are nitrite depleters (those that interfere with nitrite production from nitrate). In laboratory experiments, certain bacterial species have been shown to block nitrate to nitrite conversion by other oral bacteria. These nitrite depleting species are found in a commercially available oral probiotic designed to improve oral health. The purpose of this study is to examine if use of the probiotic negatively affects the Nitrate-Nitrite-NO cycle. Nitrate to Nitrite conversion will be assessed by measuring plasma levels of nitrite before and after consumption of nitrate-rich beetroot juice. Dietary nitrate to plasma nitrite conversion will assessed at baseline and after one week of consumption of the probiotic or a placebo (follow-up). The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to baseline and that there will be no significant change in nitrate to nitrite conversion between baseline and follow-up for participants who consume the placebo. While this study does not aim to treat any specific disease, it is intended to elucidate a basic physiological function that may be relevant to cardiovascular health and certain NO-based therapeutics. Type: Interventional Start Date: Jun 2024 |
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Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Veno1
Scott C. Woller, MD
Venous Thromboembolic Disease
Pulmonary Embolism and Thrombosis
Deep Vein Thrombosis
Hospitalism
A new algorithm derived from only patient age and components of the complete blood count
and basic metabolic panel can identify patients discharged from the hospital who may
benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots,
and for whom the risk of bleeding is1 expand
A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal. The purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low. The pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients. Type: Interventional Start Date: Jun 2024 |
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Charcot-Marie-Tooth Disease (CMT) Biological Sample Collection for IPSC Generation and Biobanking
New York Stem Cell Foundation Research Institute
Charcot-Marie-Tooth Disease
Healthy
The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research
to accelerate Charcot-Marie-Tooth disease research and drug development by using cells
from the body (such as skin or blood cells) to make stem cells and other types of cells,
conduct research on the samples, p1 expand
The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate Charcot-Marie-Tooth disease research and drug development by using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and/or store the samples for future use. Through this research, researchers hope to identify future treatments or even cures for Charcot-Marie-Tooth disease. Type: Observational Start Date: Sep 2022 |
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Reward Processing and Depressive Subtypes: Identifying Neural Biotypes
San Francisco Veterans Affairs Medical Center
Depression
Depressive Disorder
Major Depressive Disorder
Major Depressive Episode
Depressive Symptoms
Deficits in motivation and pleasure are common in depression, and thought to be caused by
alterations in the ways in which the brain anticipates, evaluates, and adaptively uses
reward-related information. However, reward processing is a complex, multi-circuit
phenomenon, and the precise neural mech1 expand
Deficits in motivation and pleasure are common in depression, and thought to be caused by alterations in the ways in which the brain anticipates, evaluates, and adaptively uses reward-related information. However, reward processing is a complex, multi-circuit phenomenon, and the precise neural mechanisms that contribute to the absence or reduction of pleasure and motivation are not well understood. Variation in the clinical presentation of depression has long been a rule rather than an exception, including individual variation in symptoms, severity, and treatment response. This heterogeneity complicates understanding of depression and thwarts progress toward disease classification and treatment planning. Discovery of depression-specific biomarkers that account for neurobiological variation that presumably underlies distinct clinical manifestations is critical to this larger effort. Type: Observational Start Date: Jun 2021 |
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Early Life Feeding Exposure and Infant Immune and Health Status.
University of Idaho
Maternal Behavior
Maternal Obesity
Breast Milk Collection
Infant Development
Background: Although breastfeeding has known protective effects, such as preventing
childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding
initiation rate (92%) but a significant prevalence of childhood obesity (30.5%
overweight/obese). Limited research exists on1 expand
Background: Although breastfeeding has known protective effects, such as preventing childhood obesity, the specific mechanisms remain unclear. Idaho has a high breastfeeding initiation rate (92%) but a significant prevalence of childhood obesity (30.5% overweight/obese). Limited research exists on the impact of maternal inflammation, maternal body mass index (BMI), C-reactive protein (CRP), and interleukin-6 (IL-6) concentrations in breastmilk on infant health outcomes, especially in healthy full-term infants. Objective: This study aims to expand understanding of the role of maternal inflammation on breastmilk composition and its effect on infant immune development. The investigators seek to investigate the relationship between maternal health status, breastmilk inflammatory concentrations, and balanced immune development in infants. Additionally, the investigators aim to explore the potential influence of early diet exposure, including maternal inflammatory status, on the risk of obesity and other inflammatory conditions. Methods: Healthy full-term infants (breastfed/formula-fed) and their mothers will be recruited. Maternal inflammation markers (BMI, CRP, IL-6) and immune markers in infants will be analyzed. Flow cytometry will assess immune populations. Correlations between maternal systemic inflammation, infant inflammation, and breastmilk inflammatory markers will be examined for breastfeeding mothers. Outcomes: The investigators hypothesize breastfed infants will display a more favorable anti-inflammatory profile. This study will identify factors influencing immune development and potential pathways linking early-life exposures to long-term health outcomes. Findings will inform strategies for promoting balanced immune development and elucidate the role of early diet exposure, including maternal inflammation, as a protective or risk factor for obesity and inflammatory conditions. Type: Observational Start Date: Jan 2024 |
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Beneficial or Fostering Future Struggles (B.F.F.s)? Characterizing the Role of Friends in the Devel1
University of South Carolina
Child Maltreatment
Interpersonal Relations
Victimisation
Psychopathology
Electrocardiography
The goal of this clinical trial is to investigate how the friendship experiences of
maltreated (i.e., abused and/or neglected) and non-maltreated adolescents differentially
influence their risk for adverse outcomes. The main questions it aims to answer are:
1. How do the friendships of maltreate1 expand
The goal of this clinical trial is to investigate how the friendship experiences of maltreated (i.e., abused and/or neglected) and non-maltreated adolescents differentially influence their risk for adverse outcomes. The main questions it aims to answer are: 1. How do the friendships of maltreated adolescents differ from those of non-maltreated adolescents? 2. Which friendship experiences influence the associations between maltreatment and ability to regulate stress, as well as future mental health difficulties and revictimization? Participants will: - Attend the initial study visit on the campus of the University of South Carolina with their primary caregiver and a best friend during which they will: - Complete study questionnaires - Be connected to a device that records their physical ability to manage stress - Complete a task during which they will be audio and video recorded and complete a brief assessment rating how they are feeling at different times during task completion - Depending on which research group they are placed in, be assigned to discuss their experience doing this task with their friend (intervention group) or sit quietly in a room for 5 minutes (comparison group) - The follow-up study visit will involve completion of study questionnaires online or via mail 6 months later Additionally, the participant's caregiver and friend will complete study questionnaires. Researchers will compare the intervention group (debriefs with a friend) and comparison group (sits quietly for 5 minutes) to see if the presence of and discussion with the friend influences their physical ability to regulate stress and future outcomes. Type: Interventional Start Date: Dec 2023 |
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Therapeutic Evaluative Conditioning to Reduce Adolescents' Self-injurious Thoughts and Behaviors Du1
Franciscan Hospital For Children, INC.
Self-Injurious Behavior
Suicidal Ideation
Suicide Attempts
Suicide is the 2nd leading cause of death among adolescents, with the highest risk period
for suicide being the month following psychiatric inpatient hospitalization. The
investigators propose testing a brief, scalable intervention using evaluative
conditioning aimed at reducing suicidal thoughts a1 expand
Suicide is the 2nd leading cause of death among adolescents, with the highest risk period for suicide being the month following psychiatric inpatient hospitalization. The investigators propose testing a brief, scalable intervention using evaluative conditioning aimed at reducing suicidal thoughts and behaviors among adolescents during and after inpatient hospitalization. Scalable interventions, such as the one proposed that reduce suicide risk during this markedly high-risk period, could result in large-scale decreases in suicide death. Type: Interventional Start Date: Mar 2023 |
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A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adult1
Bristol-Myers Squibb
Psoriasis
The purpose of this study is to understand the comparative effectiveness of
deucravacitinib versus apremilast in adults with plaque psoriasis. expand
The purpose of this study is to understand the comparative effectiveness of deucravacitinib versus apremilast in adults with plaque psoriasis. Type: Observational Start Date: Sep 2022 |
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Treadmill Oscillation Walking to Improve Weight Transfer During Gait Following Stroke
University of Texas at Austin
Treadmill Walking
This study aims to determine the immediate and short-term effects of treadmill
oscillation walking (TOW) exercise on hip and knee neuromechanics and gait
characteristics in individuals post-stroke. It was hypothesized that compared to
baseline, individuals poststroke (N=15) will show increased hip1 expand
This study aims to determine the immediate and short-term effects of treadmill oscillation walking (TOW) exercise on hip and knee neuromechanics and gait characteristics in individuals post-stroke. It was hypothesized that compared to baseline, individuals poststroke (N=15) will show increased hip abductor and knee extensor muscle activity and torque production, and increased limb loading and walking speeds during TOW and following a 6-week TOW intervention, reflecting that TOW can enhance gait function through improved hip and knee neuromechanical activation. Type: Interventional Start Date: Dec 2022 |
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Using Electrophysiology to Index Non-invasive Brain Stimulation Effects on Reward System Functionin1
San Francisco Veterans Affairs Medical Center
Major Depressive Disorder
Depression is a leading cause of morbidity and mortality, conferring substantial
healthcare and societal costs. By studying methods to non-invasively target neural
circuitry involved in reward responsivity, information generated by this project will
improve understanding of the circuit alterations1 expand
Depression is a leading cause of morbidity and mortality, conferring substantial healthcare and societal costs. By studying methods to non-invasively target neural circuitry involved in reward responsivity, information generated by this project will improve understanding of the circuit alterations that underlie motivation and pleasure deficits in depression, and could also lead to the development of biologically-based markers of neurostimulation-based treatment response. Type: Interventional Start Date: Oct 2021 |
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Testing Tumor Tissue and Blood to Help Select Personalized Treatments for Patients With Suspected L1
Lung Cancer Mutation Consortium
NSCLC
This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium
(LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to
determine the feasibility of comprehensive molecular profiling to detect actionable
oncogenic drivers in patients with suspected1 expand
This collaborative screening protocol, developed by the Lung Cancer Mutation Consortium (LCMC) and supported by the Thoracic Surgery Oncology Group (TSOG), is designed to determine the feasibility of comprehensive molecular profiling to detect actionable oncogenic drivers in patients with suspected early stage lung cancers scheduled to undergo biopsies to establish the diagnosis of lung cancer. The primary purpose of this testing is to determine the presence of 12 oncogenic drivers (mutations in EGFR, BRAFV600E , MET exon 14, KRAS G12C and HER2, rearrangements in ALK, RET, NTRK, EGFR exon 20 insertion and ROS1, and amplification of MET and HER2) that can serve as targets making patients eligible for upcoming targeted neoadjuvant therapy trials. The ultimate goal is to use this information from the screening process to select the optimal neoadjuvant therapy and wherever possible enroll patients onto separate neoadjuvant therapy trials with genomically matched treatments or other appropriate trials if no actionable driver mutation is detected. Thoracic Surgery Oncology Group (TSOG) is a network of surgeons within North American Thoracic Surgery Academic Centers aligned with the goal of enhancing patient care through administration of multi-site trials focused on recent advances in lung cancer. TSOG has aligned with the LCMC4 sites to enroll the LCRF-LEADER screening trial. TSOG's involvement will be essential in trial enrollment and ultimate interpretation of the multimodal clinical and translational data collected as part of this study. We estimate we will detect an actionable oncogenic driver in 33% of cases. The remaining 66% of patients will represent a cohort identified by their care teams as candidates for other potential neoadjuvant therapies which may include checkpoint inhibitors such as atezolizumab, durvalumab, nivolumab, and pembrolizumab or other novel agents. The targeted therapy treatment trials will be conducted independently of the LCRF-LEADER screening trial, evaluating for efficacy. If none of the 10 oncogenic drivers are detected, the patient will be offered participation in any clinical trial of neoadjuvant therapy available at their treating institution or standard of care therapy. For patients not enrolled on a targeted treatment trial, circulating tumor DNA in blood (ctDNA) will be collected at 3 time points: before neoadjuvant treatment, after neoadjuvant treatment but before surgery, and after surgery. This initiative will be correlated with various clinical outcomes. Prespecified clinical data will be collected for correlation with these circulating biomarkers. Type: Observational Start Date: Jun 2022 |
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Natural History Study of Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate1
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Leukoencephalopathies
LBSL
Leukoencephalopathy With Brainstem and Spinal Cord Involvement and Lactate Elevation
White Matter Disease
Ataxia, Cerebellar
In this study, we will conduct retrospective chart and imaging reviews and prospective
longitudinal virtual assessments of individuals with LBSL. expand
In this study, we will conduct retrospective chart and imaging reviews and prospective longitudinal virtual assessments of individuals with LBSL. Type: Observational Start Date: Apr 2018 |