Clonal Hematopoiesis Chemotherapy and Radiation Effects Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Samples.
- Who it may be relevant to
- Registry conditions: Lung Cancer (Diagnosis), Osteochondroma, Spitz Nevus, Solid Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- Other Samples
Tissue samples will be collected during a routine visit. Participants will be asked to donate any of the following tissue types: Blood, Buccal swab (saliva) or mouthwash, Urine, Stool, Biopsy or surgical tissue (i.e., bone marrow),Bodily fluids, Other tissues
Primary outcome measures
- Prevalence of clonal hematopoiesis [Time frame: Baseline]
- Gene distribution of clonal hematopoiesis [Time frame: baseline]
- Change in clonal hematopoiesis variant allele fraction [Time frame: Up to 5 years; assessed at time 0, 6 months, and annually]
- Solid malignancy progression [Time frame: Up to 5 years]
- Overall survival [Time frame: Up to 5 years]
- Development of hematologic toxicity [Time frame: Up to 5 years]
- Development of therapy-related myeloid neoplasm (t-MN) [Time frame: Up to 10 years]
Secondary outcome measures (1)
- Development of a predictive algorithm for adverse clinical outcomes in patients with clonal hematopoiesis [Time frame: Up to 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Dana-Farber Cancer Institute — Boston
Publications
- Weeks LD, Ebert BL. Clonal Hematopoiesis as a Driver of Solid Tumors. N Engl J Med. 2025 Apr 24;392(16):1654-1656. doi: 10.1056/NEJMe2504775. No abstract available. PMID 40267434
- Morganti S, Gibson CJ, Jin Q, Santos K, Patel A, Wilson A, Merrill M, Vincuilla J, Stokes S, Lipsyc-Sharf M, Parker T, King TA, Mittendorf EA, Curigliano G, Hughes ME, Stover DG, Tolaney SM, Weeks LD, Tayob N, Lin NU, Garber JE, Miller PG, Parsons HA. Prevalence, Dynamics, and Prognostic Role of Clonal Hematopoiesis of Indeterminate Potential in Patients With Breast Cancer. J Clin Oncol. 2024 Nov; PMID 38190580
- Weeks LD, Ebert BL. Causes and consequences of clonal hematopoiesis. Blood. 2023 Dec 28;142(26):2235-2246. doi: 10.1182/blood.2023022222. PMID 37931207
- Weeks LD, Niroula A, Neuberg D, Wong W, Lindsley RC, Luskin M, Berliner N, Stone RM, DeAngelo DJ, Soiffer R, Uddin MM, Griffin G, Vlasschaert C, Gibson CJ, Jaiswal S, Bick AG, Malcovati L, Natarajan P, Ebert BL. Prediction of risk for myeloid malignancy in clonal hematopoiesis. NEJM Evid. 2023 May;2(5):10.1056/evidoa2200310. doi: 10.1056/evidoa2200310. Epub 2023 Apr 25. PMID 37483562
Identifiers
NCT: NCT07675967 · 24-431