Identification of Patients With Age-Related Clonal Hematopoiesis (ARCH) Among Cancer Survivors.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Referral to cardiology clinic
研究概览
简要总结
The purpose of this study is to see if patients with cancer have a certain amount of genetic mutations in their blood. If certain levels of mutations are found in specific genes, patients may have a condition known as ARCH. The prevalence of ARCH is higher in cancer patients who received prior chemotherapy or radiation. Studying ARCH from your blood samples may also help researchers predict which patients are more likely to be prone to heart disease. Patients who are about to start chemotherapy/radiation, and patients who have completed chemotherapy/radiation will be approached to measure the incidence of ARCH. 5-10mL blood samples will be collected before and after treatment, and if ARCH is detected in a laboratory analysis, another blood sample will be collected. Patients with ARCH will repeat the blood collection yearly, and also be referred to a cardiology clinic for follow up.
详细描述
This is a non-randomized, single-centre, observational study assessing the incidence of ARCH in cancer survivors. Patients over the age of 60 who had or will receive chemotherapy and/or radiation therapy for solid or hematologic malignancies at the Princess Margaret Cancer Centre will be considered. Based on the time point of treatment, patients will either fall into a post or prior chemotherapy/radiation cohort. Peripheral blood will be taken and will be sequenced for ARCH DNA mutations. Patients who have ARCH-related mutations at a variable allele frequency (VAF) of at least 0.5% we will repeat the genetic sequencing yearly to assess changes in mutational spectrum and VAF over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
结局指标
主要结局
Referral to cardiology clinic
时间窗: 6-12 months
次要结局
- The incidence of ARCH stratified by tumor type.(6-12 months)