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
Conditions
Keywords
Adult cancer survivors, Precursor Lesions, clonal hematopoiesis, chemotherapy, radiation, therapy-related myeloid neoplasms, CCUS, clonal hematopoiesis of indeterminate potential
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.
Detailed description
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.
Interventions
OTHERSamples
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
Sponsors
Dana-Farber Cancer Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of clonal hematopoiesis | Baseline | 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. |
| Gene distribution of clonal hematopoiesis | baseline | Distribution of genes mutated among subpopulation with clonal hematopoiesis in population of adults receiving chemotherapy and radiation therapy for solid malignancy. |
| Change in clonal hematopoiesis variant allele fraction | Up to 5 years; assessed at time 0, 6 months, and annually | 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. |
| Solid malignancy progression | Up to 5 years | 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. |
| Overall survival | Up to 5 years | Overall survival in relation to the presence of clonal hematopoiesis, based on abstracted date of death and cause of death. |
| Development of hematologic toxicity | Up to 5 years | 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. |
| Development of therapy-related myeloid neoplasm (t-MN) | Up to 10 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of a predictive algorithm for adverse clinical outcomes in patients with clonal hematopoiesis | Up to 5 years | 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. |
Countries
United States
Contacts
CONTACTCindy Amaya Lopez, BA
CONTACTJenna Beckwith, MPH
PRINCIPAL_INVESTIGATORLachelle D Weeks, MD, PhD
Dana-Farber Cancer Institute
Outcome results
None listed