Health Trials

Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

ConditionsLung Cancer (Diagnosis)OsteochondromaSpitz NevusSolid CancersBreast CancerGastric (Stomach) CancerColorectal (Colon or Rectal) CancerSarcomaOvarian AdenocarcinomaUterine AdenocarcinomaEndometrial AdenocarcinomaEsophageal AdenocarcinomaHead and Neck CancerTherapy-Related Acute Myeloid LeukemiaTherapy-Related MDSClonal Hematopoiesis of Indeterminate Potential (CHIP)Clonal Cytopenia of Undetermined Significance
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Samples

Treatment groups

5,000 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Dana-Farber Cancer Institute

Lead sponsor

Source ClinicalTrials.gov