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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

This trial does not accept healthy volunteers

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 population

Participants to be included in this study include patients who have a diagnosis of solid cancer for which they are planning to receive cytotoxic chemotherapy, radiation, or PARP inhibitor therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Samples

    Other intervention

    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

Treatment groups

5,000 Participants
are divided into 3 treatment groups
Group A: HEREDITARY RISK1 intervention
Group B: EXPOSED HIGH RISK1 intervention
Group C: PRECURSOR LESIONS1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of clonal hematopoiesis

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.

Time frame
Baseline
2

Gene distribution of clonal hematopoiesis

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

Time frame
baseline
3

Change in clonal hematopoiesis variant allele fraction

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.

Time frame
Up to 5 years; assessed at time 0, 6 months, and annually
4

Solid malignancy progression

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.

Time frame
Up to 5 years

Secondary outcomes

1

Development of a predictive algorithm for adverse clinical outcomes in patients with clonal hematopoiesis

Aggregate study data will be utilized to identify features most predictive of adverse clonal hematopoiesis-related outcomes in patients receiving chemotherapy and/or radiation for solid malignancies. These features will be combined into the development of a predictive algorithm that is capable of identifying patient populations at-risk for t-MN.

Time frame
Up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Source ClinicalTrials.gov
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