Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 435
- 试验地点
- 21
- 主要终点
- The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
研究概览
简要总结
The objective of this study is to confirm the sensitivity of a stool DNA test for detection of colorectal cancer and pre-cancer.
Another objective is to provide anonymous, clinically characterized specimens for a bio-repository for future colorectal cancer-related test development.
详细描述
Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of submitting blood and tissue samples for future colo-rectal cancer-related test development.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female, 40-90 years of age, inclusive.
- •Subject has a diagnosis of CRC, at any stage, confirmed with a tissue biopsy and/or ≥1 cm colorectal polyp/adenoma/mass identified on a colonoscopy that is of sufficient size to require surgical excision or complex colonoscopic polypectomy.
- •Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
排除标准
- •Subject has active synchronous extra-colonic aerodigestive tract cancers (e.g., lung, esophagus, stomach, or pancreatic cancer).
- •Subject has a history of any inflammatory bowel disease.
- •Subject has familial adenomatous polyposis, hereditary non-polyposis colorectal cancer (Lynch) syndrome, or other hereditary cancer syndromes.
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
结局指标
主要结局
The primary endpoints are point estimates of the sensitivity of the diagnostic tests for detection of colorectal neoplasms.
时间窗: 12 Months
The diagnostic test under development is a multi-marker stool test for detecting CRC and pre-cancer in a general screening application. The primary objective of this study is to confirm the sensitivity of the optimal DNA marker panel.
次要结局
- To collect samples from patients diagnosed with colorectal cancers.(12 Months)