Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07675967
Status
Recruiting
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Conditions

  • Breast Cancer
  • Clonal Cytopenia of Undetermined Significance
  • Clonal Hematopoiesis of Indeterminate Potential (CHIP)
  • Colorectal (Colon or Rectal) Cancer
  • Endometrial Adenocarcinoma
  • Esophageal Adenocarcinoma
  • Gastric (Stomach) Cancer
  • Head and Neck Cancer
  • Lung Cancer (Diagnosis)
  • Osteochondroma
  • Ovarian Adenocarcinoma
  • Sarcoma
  • Solid Cancers
  • Spitz Nevus
  • Therapy-Related Acute Myeloid Leukemia
  • Therapy-Related MDS
  • Uterine Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Samples — OTHER
    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

Study Details

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.

Key Dates

Start date
Apr 4, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Mar 31, 2035

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: HEREDITARY RISK
    Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash.
  • Arm: EXPOSED HIGH RISK
    Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash.
  • Arm: PRECURSOR LESIONS
    Participants will also be asked to complete an intake survey that will include questions about demographics, medical history and family history data. Tissue samples will be collected during a routine visit or at patient's home via remote collection. Participants will be asked to donate any the following tissue types: - Blood - Buccal swab (saliva) or mouthwash.

Primary Outcome Measure

Prevalence of clonal hematopoiesis [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Breast cancerHead and neck cancer
By specialty
OncologyBreast oncologyWomen's healthENT
By research site
Dana-Farber Cancer Institute· Boston, MA

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