Clonal Hematopoiesis Chemotherapy and Radiation Effects Study
Recruiting · NCT07675967 · Observational (researchers observe without assigning treatment) · Lead sponsor: Dana-Farber Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed across 1 US state.
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States