Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT07675967

Conditions

Lung Cancer (Diagnosis)

Osteochondroma

Spitz Nevus

Solid Cancers

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Samples

Study Details

Brief summary:

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.

Conditions

Lung Cancer (Diagnosis)

Osteochondroma

Spitz Nevus

Solid Cancers

Breast Cancer

Study ID

NCT07675967

Start date

Apr 4, 2025

Status verified date

Jun, 2026

Completion date

Mar 31, 2035

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

Samples

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

Primary outcome measure

  • Prevalence of clonal hematopoiesis [ Time Frame: Baseline ]
  • Gene distribution of clonal hematopoiesis [ Time Frame: baseline ]
  • Change in clonal hematopoiesis variant allele fraction [ Time Frame: Up to 5 years; assessed at time 0, 6 months, and annually ]
  • Solid malignancy progression [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]
  • Development of hematologic toxicity [ Time Frame: Up to 5 years ]
  • Development of therapy-related myeloid neoplasm (t-MN) [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

Cindy Amaya Lopez, BA

857-215-1943DFCICHCARESTUDY@DFCI.HARVARD.EDU

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Keywords

  • Adult cancer survivors
  • Precursor Lesions
  • clonal hematopoiesis
  • chemotherapy
  • radiation
  • therapy-related myeloid neoplasms
  • CCUS
  • clonal hematopoiesis of indeterminate potential

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-06-30.