Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- sensitivity and specificity of a blood test
研究概览
简要总结
Colorectal cancer (CRC) is the third most common cancer in men and the second in women with an incidence of 43,350 new cases in 2018. This incidence is increasing every year.
Early detection is crucial in this pathology. In France, free screening is organized by health insurance for people aged 50 to 74 years. This screening is based on an immunological test (FIT: Fecal Immunological test), which aims to detect the presence of blood in the stool. In fact, some polyps or cancers cause bleeding that is often minimal and therefore difficult or even impossible to detect with the naked eye.
If this test is positive, a colonoscopy is done to check whether or not abnormalities are present in the colon or rectum. Performed under anesthesia, this examination can detect the possible presence of polyps or cancer.
Recently, with the covid-19 epidemic, the investigators were faced with an extension of the delays for colonoscopies which led to delays in patient care.
To prevent this, they propose to develop a blood test that would allow rapid identification of patients with colorectal cancer, requiring rapid management.
This blood test will permit to have a parameter for stratifying the therapeutic care in the event of epidemia or situation that constrains the organisation of the health system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged more than18 years
- •Cohort A : patients with suspected colorectal cancer following a positive immunological test during screening (presence of blood detected in the stool) or with gross bleeding OR Cohort B : patients who have already performed colonoscopy (on symptoms, or because of family history, or other ...), for whom the diagnosis of adenocarcinoma was identified by pathology prior to surgery, candidates for surgery on their colorectal tumor
- •Signed and dated informed consent
- •Patient affiliated to or beneficiary of French social security system.
排除标准
- •Vulnerable persons according to the law (minors, adults under protection, persons deprived of liberty ...)
- •Not ability to comply with the study protocol, in the Investigator's judgment
- •pregnant woman
- •Patient in the period of exclusion of another study
研究组 & 干预措施
Blood test
In Cohort A: 200 patients with suspected colorectal cancer following a positive immunological test during screening (presence of blood detected in the stool) OR with gross bleeding
In cohort B: 200 patients who have already performed colonoscopy candidates for surgery on their colorectal tumor
干预措施: Blood sample (Diagnostic Test)
Blood test
In Cohort A: 200 patients with suspected colorectal cancer following a positive immunological test during screening (presence of blood detected in the stool) OR with gross bleeding
In cohort B: 200 patients who have already performed colonoscopy candidates for surgery on their colorectal tumor
干预措施: Tumor tissue (Other)
Blood test
In Cohort A: 200 patients with suspected colorectal cancer following a positive immunological test during screening (presence of blood detected in the stool) OR with gross bleeding
In cohort B: 200 patients who have already performed colonoscopy candidates for surgery on their colorectal tumor
干预措施: stool collection (Other)
结局指标
主要结局
sensitivity and specificity of a blood test
时间窗: one month after surgery, an average of 6 months from inclusion
correlation between the biological signature of the test and the stage of the disease in patients whose diagnosis of adenocarcinoma was identified by pathology prior to surgery.
时间窗: one month after surgery, an average of 6 months from inclusion
次要结局
未报告次要终点