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Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Cindy Amaya Lopez, BA
DFCICHCARESTUDY@DFCI.HARVARD.EDU
857-215-1943
Backup
Jenna Beckwith, MPH
Time Frame
Start Date: 2025-04-04
Estimated Completion Date: 2035-03-31
Participants
Target number of participants: 5000
Treatments
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.
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov