African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 854
- 试验地点
- 2
- 主要终点
- Immunohistochemistry
研究概览
简要总结
The goal of this study is to develop a comprehensive characterization of genetic and molecular drivers of breast and prostate cancer in individuals of African ancestry. The study is conducted by the African Caribbean Cancer Consortium (AC3) and involves the recruitment of patients from nine international AC3 research sites in the Bahamas, Barbados, Benin, Burkina Faso, Haiti, Jamaica, Kenya, Namibia, and Trinidad and Tobago, and the US. The main questions are to: molecularly characterize genomic changes in the African Cancer genomes of the breast and prostate and identify the effects of social determinants of health and lifestyle factors on mutational landscape. Black individuals that have been diagnosed with pathologically confirmed prostate or breast cancer will be included. Detailed social determinants of health survey, blood and archived FFPE tissues will be collected. (Tier 1) All patient tissues will be subject to IHC for receptor status (ER, AR, PR Her2/neu). All patients with available germline DNA from blood will receive genetic screening using a Commercial gene panel testing. (Tier 2) Patient samples with a negative genetic screening will be subject to whole exome sequencing or banked for later RNA or methylation sequencing.
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 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 18-85 years of age, diagnosed with a pathologically confirmed cancer at any stage at diagnosis. Participant can have a history of a previous cancer we will control for previous history of cancer diagnosis in our analysis.
排除标准
- •Patients age <18 year, incarcerated patients, and patients whose medical decisions are made by proxy will be excluded.
结局指标
主要结局
Immunohistochemistry
时间窗: Year 1-2
ER, PR, Her2 and AR status in breast and prostate tissues
Germline Mutations
时间窗: Year 1-2
Hereditary mutations in germline DND from breast and prostate
Mutational Landscape
时间窗: Year 2
tumor mutation burden in breast and prostate tissues
次要结局
未报告次要终点
研究者
Camille Ragin, PhD, MPH
Professor
Fox Chase Cancer Center
