Exploratory Study of a Novel Based rbcDNA Liquid Biopsy Technique for Colorectal Cancer Early Detection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 598
- 试验地点
- 1
- 主要终点
- Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening
研究概览
简要总结
Exploration of a novel rbcDNA liquid biopsy technique for early detection of colorectal cancer is a promising development in the field of disease diagnosis and screening. This technique has the potential to establish an efficient and sensitive system for the early detection of colorectal cancer, which can provide a new perspective for individual health monitoring.
详细描述
Patients who are at high risk of developing colorectal cancer and willing to undergo colonoscopy examination will be asked to collect a stool sample prior to bowel preparation for commercially available FIT (fecal immunochemical test) assay, as well as a blood sample for rbcDNA testing. The colonoscopy and histopathologic examination will be used as a reference for the results obtained from these tests.
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
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age:40-74Years
- •Willing to provide written consent
- •Plan to undergo colorectaloscopy or surgical treatment and be able to provide a complete medical history and cooperate with blood sampling and follow-up visits，other operation.
- •For advanced adenomas (AA) group:
- •Adenomatous polyps with ≥25% villous component, high-grade dysplasia (HGD), or a diameter ≥10 mm were considered AA. Sessile serrated lesions with diameters ≥10 mm.
- •treatment-naive
- •No other comorbid tumors
- •For CRC group:
- •Confirmed CRC patients
- •treatment-naive
- •No other comorbid tumors
排除标准
- •Patients with colorectal cancer who have received prior treatment.
- •FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis
- •Participants taking anticoagulants such as aspirin or warfarin, or those with coagulation disorders.
- •Prior history of colonoscopy within the past 5 years and removal of lesions
- •Pregnancy or intestinal infarction people
- •Unable to provide informed consent
- •Participants in other clinical trials or who have participated in other clinical trials within 60 days.
- •Unable to provide stool sample and follow-up visits.
- •Presence of major infectious diseases (e.g. HIV, etc.)
结局指标
主要结局
Evaluating the sensitivity, specificity, and accuracy of rbcDNA in colorectal cancer screening
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 rbcDNA test was deployed to a composite score. The tests were processed independently of colonoscopy procedure.
次要结局
- Sensitivity of the rbcDNA 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
Jun Li
Chief
Second Affiliated Hospital, School of Medicine, Zhejiang University