RecruitingNot Applicable

Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

United States5,000 participantsStarted 2025-04-04

Plain-language summary

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 participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prevalence of clonal hematopoiesis

Timeframe: Baseline

Gene distribution of clonal hematopoiesis

Timeframe: baseline

Change in clonal hematopoiesis variant allele fraction

Timeframe: Up to 5 years; assessed at time 0, 6 months, and annually

Solid malignancy progression

Timeframe: Up to 5 years

Overall survival

Timeframe: Up to 5 years

Development of hematologic toxicity

Timeframe: Up to 5 years

Development of therapy-related myeloid neoplasm (t-MN)

Timeframe: Up to 10 years

Trial details

NCT IDNCT07675967

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-06-30

Contact for this trial

Cindy Amaya Lopez, BA

857-215-1943 DFCICHCARESTUDY@DFCI.HARVARD.EDU

View on ClinicalTrials.gov More Lung Cancer (Diagnosis) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Prevalence of clonal hematopoiesis

Timeframe: Baseline

Gene distribution of clonal hematopoiesis

Timeframe: baseline

Change in clonal hematopoiesis variant allele fraction

Timeframe: Up to 5 years; assessed at time 0, 6 months, and annually

Solid malignancy progression

Timeframe: Up to 5 years

Overall survival

Timeframe: Up to 5 years

Development of hematologic toxicity

Timeframe: Up to 5 years

Development of therapy-related myeloid neoplasm (t-MN)

Timeframe: Up to 10 years