Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers (CHANCES)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors
研究概览
简要总结
This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian or other solid cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer.
详细描述
OUTLINE: This is an observational study.
Patients undergo blood sample collection and complete surveys on study. Patients' medical records are also reviewed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and:
- •Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy
- •Subjects who have or have had a solid tumor diagnosis and any of the following:
- •At least 4 months of exposure to a PARP inhibitor
- •Diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm
排除标准
- •Individuals with a life expectancy of less than 6 months
研究组 & 干预措施
Observational
Patients undergo blood sample collection and complete surveys on study. Patients' medical records are also reviewed.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors
时间窗: Through study completion, up to 5 years
Measurement Tool: will measure by BM biopsy confirmation done by local hematologist
Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients
时间窗: Through study completion, up to 5 years
Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN
时间窗: Through study completion, up to 5 years
Measurement Tool: the variant allele fraction of the blood clone
次要结局
未报告次要终点