Ohio Prevention and Treatment of Endometrial Cancer (OPTEC) Initiative: Universal Screening for DNA Mismatch Repair Deficiency and Personalized Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,001
- 试验地点
- 18
- 主要终点
- Incidence of endometrial cancer patients with Lynch syndrome
研究概览
简要总结
This clinical trial studies universal screening for deoxyribonucleic acid (DNA) mismatch repair deficiency in patients with endometrial cancer, mutations in the genes responsible for Lynch syndrome (inherited forms of endometrial cancers) and other DNA changes that could help guide treatment strategies. Universal tumor DNA sequencing may help doctors better understand how to personalize care, increase length of life, and increase quality of life in patients with endometrial cancer and their relatives.
详细描述
PRIMARY OBJECTIVES:
I. Molecular classification of tumor abnormalities through innovative upfront next-generation DNA sequencing.
II. Identify endometrial cancer (EC) patients with inherited EC, specifically Lynch syndrome (LS), using both tumor and normal (blood) DNA testing.
III. Develop a comprehensive approach to genetic risk assessment and management including improved cascade testing in at-risk relatives.
IV. Provide local access to genetic counseling for patients with harmful germline mutations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult women who had a hysterectomy or diagnostic biopsy proving endometrial adenocarcinoma (any stage) between 10/1/2017 and 4/30/2020, and received care at one of the participating hospitals
- •Adult relatives of the EC patients found to have LS
排除标准
- •Individuals must be able to speak and read English; non-English speaking individuals will be excluded
- •Individuals must be able to consent for themselves; those who are unable to consent for themselves for any reason will be excluded
- •Prisoners will be specifically excluded from participation in the study
- •Women who have uterine sarcomas are excluded
- •Pregnant women are not eligible for the study
结局指标
主要结局
Incidence of endometrial cancer patients with Lynch syndrome
时间窗: Up to 3 years
Measured by molecular profiling of tumor deoxyribonucleic acid (DNA) via next-generation sequencing.
Incidence of tumors with microsatellite instability and/or somatic POLE mutations
时间窗: Up to 3 years
Measured by molecular profiling of tumor DNA via next-generation sequencing.
次要结局
未报告次要终点
研究者
Paul Goodfellow
Principal Investigator
Ohio State University Comprehensive Cancer Center