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.
The objective of this protocol is to obtain clinical information and facilitate the collection and distribution of specimens obtained during the course of clinical care or research participation. Blood, buccal swabs, or other body fluids may be specifically acquired for research in order to perform molecular and other types of analyses for research purposes. These materials will be collected from all eligible participants. It is expected that about 5,000 people will take part in this research study.
Study Type
OBSERVATIONAL
Enrollment
5,000
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
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGPrevalence 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
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
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
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
Overall survival
Overall survival in relation to the presence of clonal hematopoiesis, based on abstracted date of death and cause of death.
Time frame: Up to 5 years
Development of hematologic toxicity
Development of hematologic toxicity in relation to the presence of clonal hematopoiesis, using abstracted clinical and laboratory data, including CBC values and related treatment information.
Time frame: Up to 5 years
Development of therapy-related myeloid neoplasm (t-MN)
Development of therapy-related myeloid neoplasm in relation to the presence of clonal hematopoiesis, using abstracted dates of diagnosis of hematologic malignancies and related follow-up data.
Time frame: Up to 10 years
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
Jenna Beckwith, MPH
CONTACT
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