Evaluation of PreveCol's Efficiency As a Second Line Method for the Early Colorectal Cancer Detection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,538
- 试验地点
- 2
- 主要终点
- Diagnostic value
研究概览
简要总结
The objective of this low-risk interventional study is to evaluate whether the PreveCol® test has sufficient efficiency to be considered as a second-line method for the detection of both colorectal cancer and advanced adenomas when used prospectively in the screening population with a previous positive FOBT result, which could include any of the following: both sexes, age 50-69 years, asympthomatic volunteers. The main aims to be answered are:
- Values of efficacy, efficiency, impact and safety of PreveCol.
- Values of preferences of participants for screening methods.
- Values of PREMs into screening programme.
Participants will provide a blood sample prior to a screening colonoscopy, and complete two questionnaires. They will give their sample, information and clinical data to the investigator or health care personnel.
详细描述
Multicentre, international, no-competitive, prospective, transversal, and low-risk interventional study coming from average risk participants (50-69 years old) from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
盲法说明
Laboratory Technicians
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants ages from 50 to 69 years (both included) at the time of informed consent signed.
- •Participants should sign an informed consent. They must understand the nature, significance, implications, and risks of the clinical study before signing the informed consent form.
- •Participants with a positive result of FIT/FOBT analysis referred to the gastroenterology department who are eligible to undertake colonoscopy as a regular procedure of the colorectal cancer screening programme.
- •Participants asymptomatic, average risk for CRC. Average risk is defined as those individuals who are age 50 or over with no history of adenoma, colorectal cancer, or inflammatory bowel disease, and with no family history of CRC (first degree relatives).
排除标准
- •Participants who have developed any another type of cancer in the 5 years prior to their participation in the study.
- •Participants who have previously received chemotherapy or radiotherapy (5 years).
- •Participants previously or currently diagnosed with Familiar Adenomatous Polyposis or Lynch Syndrome or Inflammatory Bowel Disease.
- •Inadequate intestinal preparation for colonoscopy with BBPS score ≤1 in any colon section, excluding diagnostic of CRC.
- •Participants who have undergone polypectomy in the previous 5 years.
- •Hemolysis of blood sample or absence of blood sample.
- •Participants who are arrested at judicial or official request
- •Participants who are in a dependent personal or non-medical relationship with the Sponsor or the investigator.
研究组 & 干预措施
PreveCol test after a FOBT positive result
Average-risk participants from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy
干预措施: blood sampling (Diagnostic Test)
PreveCol test after a FOBT positive result
Average-risk participants from the colorectal cancer screening programme with FOBT positive result who are eligible to undergo colonoscopy
干预措施: Survey using a questionnaire. (Other)
结局指标
主要结局
Diagnostic value
时间窗: 12 months
Value of efficiency through the clinical performance (sensitivity, specificity, positive predictive value and negative predictive value) of PreveCol® after FOBT positive result for detecting neoplastic lesions.
次要结局
- Diagnostic performance of cancer(12 months)
- Diagnostic performance of lesions(12 months)
- Value of questionnaires into screening programme(12 months)