Clonal Hematopoiesis Chemotherapy and Radiation Effects Study
Purpose
The goal of the Clonal Hematopoiesis Chemotherapy and Radiation Effects (CH CARE) Study is to understand how the presence or absence of clonal hematopoiesis (CH) influences outcomes in people receiving chemotherapy and radiation for solid cancers. The study will collect biospecimens and clinical information. These data will be used to define clinical and molecular features that predict the presence of high-risk clonal hematopoiesis (CH) in patients exposed to cytotoxic anti-cancer therapy. Predictive features will be utilized to identify populations of cancer patients and survivors who are at the highest risk of developing therapy-related myeloid neoplasms (t-MNs). Ultimately this study will result in the development of a novel novel risk prediction algorithm for t-MNs in patients with solid cancers and drive potential therapeutic approaches to intercept progression from CH to often fatal t-MNs.
Conditions
- Lung Cancer (Diagnosis)
- Osteochondroma
- Spitz Nevus
- Solid Cancers
- Breast Cancer
- Gastric (Stomach) Cancer
- Colorectal (Colon or Rectal) Cancer
- Sarcoma
- Ovarian Adenocarcinoma
- Uterine Adenocarcinoma
- Endometrial Adenocarcinoma
- Esophageal Adenocarcinoma
- Head and Neck Cancer
- Therapy-Related Acute Myeloid Leukemia
- Therapy-Related MDS
- Clonal Hematopoiesis of Indeterminate Potential (CHIP)
- Clonal Cytopenia of Undetermined Significance
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants to be included in this study include the following: - Adults age >18 years - Diagnosed with solid malignancy (breast, ovarian, lung, gastric, colorectal, esophageal, uterine, head and neck, or sarcoma cancers) - Have a pending plan to receive chemotherapy or radiation for their solid malignancy (cancer). - Has not received cytotoxic chemotherapy or radiation for their solid cancer diagnosis in the past.
Exclusion Criteria
- Individuals without plans for cytotoxic chemotherapy, radiation or PARP inhibitor exposure - Individuals who have received prior chemotherapy and or radiation for their current solid malignancy (cancer) - Individuals with any prior history of blood cancer (leukemia, myelodysplastic syndrome, lymphoma, multiple myeloma, including smoldering multiple myeloma). Persons with blood cancer precursors including clonal hematopoiesis of indeterminate potential (CHIP), clonal cytopenia of uncertain significance (CCUS), monoclonal B lymphocytosis (MBL), monoclonal gammopathy of uncertain significance (MGUS) are eligible for study participation.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| HEREDITARY RISK | Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash. |
|
| EXPOSED HIGH RISK | Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash. |
|
| PRECURSOR LESIONS | Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash. |
|
Recruiting Locations
Boston, Massachusetts 02115
More Details
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
Detailed Description
The objective of this protocol is to obtain clinical information and facilitate the collection and distribution of specimens obtained during the course of clinical care or research participation. Blood, buccal swabs, or other body fluids may be specifically acquired for research in order to perform molecular and other types of analyses for research purposes. These materials will be collected from all eligible participants. It is expected that about 5,000 people will take part in this research study.