Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood test | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Diagnostic Test | In cohort A: Blood sample n°1 (PBMC, plasma, ctDNA) previous colonoscopy. If no cancer lesions: STOP. If cancer lesion detected : Blood sample n°2 (PBMC, plasma, ctDNA) collected 1 month after surgery. In cohort B: Blood sample n°1 (PBMC, plasma, ctDNA) collected before surgery. Blood sample n°2 (PBMC, plasma, ctDNA) collected 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| sensitivity and specificity of a blood test | 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. | one month after surgery, an average of 6 months from inclusion |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christophe BORG, Pr | Contact | +33381668166 | christophe.borg@efs.sante.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Recruiting | Besançon | France | |||
| Hôpital Nord-Franche-Comté |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Tumor tissue | Other | In each cohort, tumor tissue will be collected from the surgical specimen. |
|
| stool collection | Other | In cohort B: Stool sample n°1 collected before surgery. Stool sample n°2 collected 1 month after surgery |
|
| Not yet recruiting |
| Montbéliard |
| France |
| Centre Hospitalier Intercommunal de Haute-Saône | Not yet recruiting | Vesoul | France |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided