Stool KRAS Mutation, BMP3/NDRG4 Methylation and FIT Panel Test for the Detection of Colorectal Advanced Neoplasia in High Risk Chinese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,758
- 试验地点
- 8
- 主要终点
- Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy
研究概览
简要总结
The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multitarget FIT-DNA test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.
详细描述
The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at high risk of developing colorectal cancer and willing to conduct colonoscopy examination will be asked to collect stool sample prior to bowl preparation for multitarget FIT-DNA test and commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to provide written consent
- •Able to provide stool sample
- •For high risk CRC screening group:
- •Scheduled for colonoscopy voluntarily or by physician prescription
- •CRC high risk profile as defined below:
- •History of FIT positivity
- •Family history of CRC
- •Any of two of the following clinical symptoms: chronic constipation/diarrhea, stool with mucous, chronic appendicitis, chronic bilary track diseases, mental stress
- •For CRC group:
- •Confirmed CRC patients
- •No prior treatment with chemotherapy, radiotherapy, and prior to any surgical procedures
排除标准
- •Unwilling to provide stool samples
- •FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis
- •Prior history of colonoscopy within the past 5 years and removal of lesions
- •History of CRC
- •other conditions deemed not suited for the study by investigators
结局指标
主要结局
Sensitivity and specificity of the ColoClear screening test with comparison to colonoscopy
时间窗: Through study completion, an average of 1 year
A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant by histopathologic examination. The DNA test includes molecular assays for KRAS mutations, aberrant NDRG4 and BMP3 methylation, plus a hemoglobin immunoassay. A logistic-regression algorithm incorporating all the above parameters was deployed to compute a single composite score, with values of 165 or more considered to be positive. The tests were processed independently of colonoscopy procedure.
次要结局
- Sensitivity of the ColoClear screening test with comparison to FIT, with respect to advanced adenoma (AA) and CRC(Through study completion, an average of 1 year)
研究者
Ding Ke-Feng
Chief physician
Zhejiang University