Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

This study, called CH CARE, aims to understand how a condition called clonal hematopoiesis (CH) affects people receiving chemotherapy or radiation for solid cancers like breast or lung cancer. CH is a change in blood stem cells. Researchers will collect tissue samples, such as blood, urine, or biopsy tissue, during your regular visits. They will look at these samples to find out how common CH is and how it changes over time, up to five years. This information will help identify cancer patients who might be at higher risk for certain blood disorders after cancer treatment. You can join if you are over 18, have a solid cancer, and are planning to receive chemotherapy or radiation.

Study design
This is an observational study, meaning researchers will collect information and samples without giving new treatments. About 5,000 people are expected to participate.
What's involved
You would provide tissue samples (like blood, saliva, urine, or biopsy tissue) during routine visits. These samples will be collected at the start, at 6 months, and annually for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years, with assessments at the start, 6 months, and annually.

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NCT07675967

Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

Recruiting
Not specifiedAges 18+Observational
Dana-Farber Cancer Institute
~5,000 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Samples

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Prevalence of clonal hematopoiesis
Measured over Baseline
+6 more outcomes measured
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
1 sites across 1 states
Massachusetts1
  • Lachelle D Weeks, MD, PhD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

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Eligibility criteria

Inclusion

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

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.
  • Prevalence of clonal hematopoiesisBaseline

    Prevalence of clonal hematopoiesis detected by the study's targeted unique molecular identifier-based sequencing panel in population of adults with advanced non-metastatic solid cancers.

  • Gene distribution of clonal hematopoiesisbaseline

    Distribution of genes mutated among subpopulation with clonal hematopoiesis in population of adults receiving chemotherapy and radiation therapy for solid malignancy.

  • Change in clonal hematopoiesis variant allele fractionUp to 5 years; assessed at time 0, 6 months, and annually

    Change in clonal hematopoiesis allelic fractions over follow-up in patients receiving chemotherapy and radiation for advanced non-metastatic solid malignancy, based on serial sequencing of stored blood specimens.

  • Solid malignancy progressionUp to 5 years

    Solid malignancy progression in relation to the presence of clonal hematopoiesis, based on clinical progression data abstracted from the electronic health record and follow-up data collected under protocol 22-200.

  • Overall survivalUp to 5 years

    Overall survival in relation to the presence of clonal hematopoiesis, based on abstracted date of death and cause of death.

  • Development of hematologic toxicityUp to 5 years

    Development of hematologic toxicity in relation to the presence of clonal hematopoiesis, using abstracted clinical and laboratory data, including CBC values and related treatment information.

  • Development of therapy-related myeloid neoplasm (t-MN)Up to 10 years

    Development of therapy-related myeloid neoplasm in relation to the presence of clonal hematopoiesis, using abstracted dates of diagnosis of hematologic malignancies and related follow-up data.