Dysautonomia International

A Study of Lung Cancer Screening in People With Unexplained Weight Loss

Purpose

The researchers are doing this study to see if people with unexplained weight loss who have lung cancer screening are more likely to have or develop lung cancer than people without unexplained weight loss. The lung cancer screening will involve use of low-dose computed tomography (LDCT), a CT scan that gives off very low doses of radiation and can make detailed pictures of the lungs to help find tumors. The study researchers will also analyze participants' blood samples to determine if blood testing can be used to help to diagnose lung cancer.

Condition

Lung Cancer Screening

Eligibility

Eligible Ages: Between 50 Years and 80 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

Eligible for American Cancer Society lung cancer screening, as follows as per the discretion of the screening team: - Age 50-80 years old - At least 20-pack year history of smoking - Weight loss of 3-10%, defined as UWL, within any timeframe over the past in the 18 months prior to enrollment, that cannot be attributed to an underlying medical condition at the discretion of the enrolling investigator - Note that patients who have 3-10% weight may still be enrolled if the enrolling investigator does not conclude that the weight loss can be attributed to the patient's intentional efforts. - Documented weight loss can be self-reported or extracted from weights obtained during physician visits. However, if self-reported weight loss is contradicted by weight loss documented in the medical record (e.g. a patients states that (s)he lost 10 lbs in the past 6 months, but a weight documented in the medical record does not support that history), the measured and quantified weight change will be used to ascertain eligibility - Life expectancy greater than 1 year, per assessment of the treating clinician.

Exclusion Criteria

Currently pregnant or trying to become pregnant via self-report - Prior history of recent CT scan of the chest either through LDCT screening or with a scan of the chest (standard, not LDCT) performed within the past 12 months - Prior history of NSCLC ○ Note that patients with a history of diagnosis of non-lung cancers are eligible for the study. - Currently undergoing or referred for diagnostic evaluation due to clinical suspicion for malignancy (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality). - Patients with a germline pathogenic genetic variant who have undergone whole body MRI within the past 12 months - Unable to comply with study procedures

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
Patients undergoing Lung cancer screening	All patients will undergo prospective LDCT imaging annually. At baseline and Year 1, patients will also undergo biospecimen collection for post-hoc ctDNA analysis.	Diagnostic Test: Low Dose CT imaging at baseline and at Year 1. Other: blood draws at baseline and at Year 1. Other: screening questionnaire at baseline and at 1 year after registration.

Recruiting Locations

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey 07920