Validation of a ctDNA Methylation-based Dual-target Test for the Detection of Colorectal Cancer: a Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,378
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
To evaluate the effectiveness and accuracy of the ctDNA dual-target test kit in a large case-control cohort for the detection of colorectal cancer and advanced adenomas.
详细描述
Usually, colorectal cancers (CRCs) diagnosed in their early stages are curable, especially precancerous lesions (adenomas, polyps) that can be removed during a colonoscopy.However, due to low patient compliance and limited resources, colonoscopy is not feasible for screening the average-risk population. gFOBT/FIT are limited by their low sensitivity and high false-positive rate. Compared to colonoscopy and stool DNA tests, blood-based methylation tests showed greater patient compliance and convenience. Hypermethylated NTMT1 and MAP3K14-AS1 were found in multiple cohorts of CRC samples in our previous study. In this study, we aimed to evaluate the effectiveness and accuracy of the ctDNA dual-target(NTMT1 and MAP3K14-AS1) test kit in 5 tertiary hospitals around china for the detection of colorectal cancer and advanced adenomas. Fecal immunochemical test (FIT) will also privided to participants in the study. Sanger sequencing would be performed to evalute the accuracy of the dual-target methylation detection test kit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for CRC group（≥30%） 1)Patients with colorectal cancer 2)Follow-up sample subjects: Subjects who underwent resection of colorectal cancer lesions.
- •Inclusion Criteria for Control group（≤70%） Health volunteer, or subject with other diseases or physiological conditions other than colorectal cancer, including but not limited to gastritis, gastric cancer, esophagitis, rheumatoid arthritis, prostate cancer, microbes (inflammation patients), gastrointestinal bleeding, drugs (typical digestive tract medication) Population), neuroendocrine cancer, squamous cell carcinoma (squamous squamous cell carcinoma, esophageal squamous cell carcinoma);
排除标准
- •Patients who had undergone radical resection of bowel cancer (except for postoperative follow-up) and those who had received anti-tumor therapy such as radiotherapy/chemotherapy；
- •Colorectal cancer or colorectal adenoma with other malignancies；
- •Postoperative follow-up patients of colorectal cance with distant metastasis;
- •The sample size collected did not meet the detection requirements;
- •Other patients who are considered unsuitable for this study (such as pregnancy, high blood pressure, heart disease, etc., who are not suitable for colonoscopy due to physical condition).
结局指标
主要结局
Sensitivity
时间窗: Through study completion, an average of 1 year.
Sensitivity (for CRC and\\or advanced precancerous neoplasm) of this blood-based methylation dual-target test. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. Other clinically acceptable diagnostic criteria for non-intestinal diseases.
Accuracy
时间窗: Through study completion, an average of 1 year.
Accuracy of the kit for methylation detection. Validation of the methylation status of MTNT1 and MAP3K14-AS1 by Sanger sequencing.
Specificity
时间窗: Through study completion, an average of 1 year.
Specificity (for CRC and\\or advanced precancerous neoplasm) of this blood-based methylation dual-target test. A diagnostic colonoscopy procedure is the reference method. Lesions will be confirmed as malignant or precancerous by histopathologic examination. Other clinically acceptable diagnostic criteria for non-intestinal diseases.
次要结局
- Combined sensitivity(Through study completion, an average of 1 year.)
- Combined specificity(Through study completion, an average of 1 year.)
研究者
Zhaoshen Li
MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator, Clinical Professor
Changhai Hospital