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Recruiting

Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

NCT07675967 · Dana-Farber Cancer Institute
In plain English

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About this study
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.
Eligibility criteria
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
Enrollment target: 5000 participants
Age groups: adult, older_adult
Timeline
Starts: 2025-04-04
Estimated completion: 2035-03-31
Last updated: 2026-06-30
Interventions
Other: Samples
Primary outcomes
  • Prevalence of clonal hematopoiesis (Baseline)
  • Gene distribution of clonal hematopoiesis (baseline)
  • Change in clonal hematopoiesis variant allele fraction (Up to 5 years; assessed at time 0, 6 months, and annually)
Sponsor
Dana-Farber Cancer Institute · other
Contacts & investigators
ContactCindy Amaya Lopez, BA · contact · DFCICHCARESTUDY@DFCI.HARVARD.EDU · 857-215-1943
ContactJenna Beckwith, MPH · contact
InvestigatorLachelle D Weeks, MD, PhD · principal_investigator, Dana-Farber Cancer Institute
All locations (1)
Dana-Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Clonal Hematopoiesis Chemotherapy and Radiation Effects Study · TrialPath