Clonal Hematopoiesis Chemotherapy and Radiation Effects Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Prevalence of clonal hematopoiesis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Prevalence of clonal hematopoiesis
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- Development of a predictive algorithm for adverse clinical outcomes in patients with clonal hematopoiesis(Up to 5 years)
研究者
Lachelle D. Weeks, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute