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Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how clonal hematopoiesis (CH), a change in blood-forming cells, affects people getting chemotherapy or radiation for solid cancers. Researchers will collect samples and health information to help predict who may develop blood cancer after treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18.
  • Have breast, ovarian, lung, stomach, colorectal, esophageal, uterine, or head and neck cancer, or sarcoma.
  • Have a plan to receive chemotherapy or radiation for your solid cancer.
  • Have not received cell-killing chemotherapy or radiation for this cancer before.

Who can't join

  • Have no plans to receive cell-killing chemotherapy, radiation, or a PARP inhibitor, a type of cancer medicine.
  • Have already received chemotherapy or radiation for your current solid cancer.
  • Have ever had a blood cancer, including leukemia, myelodysplastic syndrome, lymphoma, or multiple myeloma, including its early form called smoldering multiple myeloma. Conditions that can come before blood cancer—CHIP, CCUS, MBL, and MGUS—do not rule you out.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 sites (1)

MA