NCT05127096Unknown不适用
Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas
适应症
试验速览
- 阶段
- 不适用
- 发起方
- CellMax Life
- 入组人数
- 1,000
- 试验地点
- 15
- 主要终点
- Sensitivity for CRC of the FirstSight test
研究概览
简要总结
The purpose of this study is to collect clinical specimens from subjects with a diagnosis of colorectal cancer/advanced adenoma or undergoing a screening colonoscopy and meeting study eligibility criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To enroll in Cohort A, a subject must:
- •Be 45-80 years of age (inclusive) at the time of screening.
- •Be recently diagnosed with primary colorectal cancer or advanced adenoma with plans to surgically remove the target lesion.
- •To enroll in Cohort B, a subject must:
- •Be 45-80 years of age (inclusive) at the time of screening.
- •Be planning to undergo a screening colonoscopy within 30 days after providing signed informed consent.
排除标准
- •To enroll in Cohort A, a subject must NOT have:
- •Inflammatory bowel disease (IBD)
- •Personal or family history of colorectal cancer syndromes or other hereditary cancer syndromes
- •To enroll in Cohort B, a subject must NOT have:
- •Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
- •Personal or family history of Familial adenomatous polyposis (FAP).
- •Personal or family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome).
- •Positive fecal occult blood testing (FOBT) within the previous 6 months.
- •Positive fecal immunochemical testing (FIT) in the previous 6 months.
- •Colorectal resection for any reason other than sigmoid diverticular disease.
- •Overt rectal bleeding within the previous 30 days.
- •Personal history of any cancer diagnosed <5 years prior.
- •Inflammatory bowel disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease.
- •Colonoscopy within the previous 9 years.
- •Barium enema, computed tomographic colonography, or sigmoidoscopy within the previous 5 years.
- •≥ 2 first-degree relatives who have been diagnosed with colorectal cancer (Note: First degree relatives include parents, siblings and offspring).
- •1 first-degree relative with CRC diagnosed before the age of
- •Have participated or be currently participating in a clinical research study in which an experimental medication has been administered during the 30 days up to and including the date of providing informed consent or may be administered through the time of the colonoscopy.
- •Have a medical condition which, in the opinion of the investigator, should preclude enrollment into the study.
结局指标
主要结局
Sensitivity for CRC of the FirstSight test
时间窗: 30 days
Specificity of the FirstSight test
时间窗: 30 days
次要结局
未报告次要终点
研究者
研究点 (15)
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