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NCT Number: NCT07675967

Clonal Hematopoiesis Chemotherapy and Radiation Effects Study

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.

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Key information

Conditions

Lung Cancer (Diagnosis) Adenocarcinoma Of Esophagus Bone Diseases Bone Diseases, Developmental Breast Cancer Breast Diseases Breast Neoplasms Clonal Cytopenia of Undetermined Significance Clonal Hematopoiesis of Indeterminate Potential (CHIP) Colonic Diseases Colonic Neoplasms Colorectal (Colon or Rectal) Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Disease Endometrial Adenocarcinoma Esophageal Adenocarcinoma Gastric (Stomach) Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Bone Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Nevi and Melanomas Nevus Nevus, Epithelioid and Spindle Cell Nevus, Pigmented Nevus, Spindle Cell Osteochondrodysplasias Osteochondroma Ovarian Adenocarcinoma Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Sarcoma Skin Diseases Skin and Connective Tissue Diseases Solid Cancers Spitz Nevus Stomach Diseases Stomach Neoplasms Therapy-Related Acute Myeloid Leukemia Therapy-Related MDS Thoracic Neoplasms Uterine Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Prevalence of clonal hematopoiesis

    Time frame: 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.

  2. Gene distribution of clonal hematopoiesis

    Time frame: baseline

    Distribution of genes mutated among subpopulation with clonal hematopoiesis in population of adults receiving chemotherapy and radiation therapy for solid malignancy.

  3. Change in clonal hematopoiesis variant allele fraction

    Time frame: 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.

  4. Solid malignancy progression

    Time frame: 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.

  5. Overall survival

    Time frame: Up to 5 years

    Overall survival in relation to the presence of clonal hematopoiesis, based on abstracted date of death and cause of death.

  6. Development of hematologic toxicity

    Time frame: 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.

  7. Development of therapy-related myeloid neoplasm (t-MN)

    Time frame: 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 outcomes

  1. Development of a predictive algorithm for adverse clinical outcomes in patients with clonal hematopoiesis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cindy Amaya Lopez, BA

CONTACT

[email protected]

857-215-1943

Jenna Beckwith, MPH

CONTACT

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Acronym: CH CARE

Important dates

Study start
2025
Primary completion
2028
Study completion
2035
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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