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临床试验/NCT05754658
NCT05754658已完成不适用

African Cancer Genome Cohort to Promote Health Equity Among Patients of African Ancestry: Characterization of Genetic and Molecular Drivers

Fox Chase Cancer Center2 个研究点 分布在 1 个国家目标入组 854 人开始时间: 2022年11月28日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Camille Ragin, PhD, MPH

Professor

Fox Chase Cancer Center

研究点 (2)

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