Evaluation of the Discriminatory Role of Blood TFPI-1 and TFPI-2 in Adult Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Area under the ROC curve (AUC) of the TFPI-1 biomarker
研究概览
简要总结
Multicenter, inter-regional, case-control study with the primary objective of evaluating the discriminative power of the blood biomarker TFPI-1 to separate patients with histologically proven CRC from an asymptomatic control population between 50 and 75 years of age with normal colonoscopy.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected colorectal cancer for which colonoscopy is indicated.
- •Patients between 50 and 75 years old, asymptomatic from the digestive point of view (for example referred for colonoscopy as part of a pre-operative check-up of an inguinal hernia or 3 months after an episode of complicated sigmoiditis), for whom a follow-up colonoscopy is indicated.
- •If the post-inclusion colonoscopy is normal, no biopsy will be performed and patients will be assigned to the control group.
- •If the colonoscopy performed after inclusion is abnormal (presence of at least one mucosal lesion), patients will be assigned to the "colorectal cancer" group or to the "polyps" group depending on the results of the anatomopathological analysis of the lesion(s)
排除标准
- •All clinical situations outside of CRC that could increase TFPI-1 or 2 blood levels: acute coronary syndrome (unstable angina, acute myocardial infarction), severe sepsis, decompensated cirrhosis, pregnancy, chronic inflammatory bowel disease (Crohn's or ulcerative colitis), colitis or radiation rectitis.
- •Endoscopic polypectomy without prior histological confirmation.
- •Emergency (occlusion or peritonitis)
- •Minor patients.
- •Persons of full age under legal protection or unable to express their consent
- •Persons not affiliated to a social security system or beneficiaries of such a system.
- •Pregnant women, women in labor or nursing mothers.
研究组 & 干预措施
Control group
All consecutive patients between 50 and 75 years of age for whom colonoscopy will be normal (no mucosal lesions). In this situation, histological examination is not performed.
Polyp group
All consecutive patients for whom colonoscopy shows mucosal lesions that will be classified as polyps after histological examination.
Case group
All consecutive patients from participating centers with an abnormal colonoscopy (presence of mucosal lesions at endoscopy), with histological confirmation of colorectal cancer. These will be patients with one or more histologically confirmed adenocarcinomatous lesions (CRC+) located in the colonic frame or rectum, with or without synchronous liver metastases.
结局指标
主要结局
Area under the ROC curve (AUC) of the TFPI-1 biomarker
时间窗: At 2 months
the AUC of the TFPI-1 biomarker to separate the 2 groups (CRC+ and control, i.e., asymptomatic population between 50 and 75 years with normal colonoscopy).
次要结局
- AUC of the discriminant score constructed by logistic regression with the 2 blood biomarkers as explanatory variables and the group type (CRC+ and control) as the variable to be explained.(At 2 months)
- AUC of the TFPI-2 biomarker to separate the 2 groups (CRC+ and control).(At 2 months)
- Extension of c-index to the 3-group case proposed by Van Calster B et al.(At 2 months)