Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening

NCT04767568 | Recruiting

• 1 other identifier: 2020/539
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

blood test; early detection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Diagnostic Test: Blood sample; Other: Tumor tissue; Other: stool collection

Interventions

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

Blood test

Tumor tissue OTHER

In each cohort, tumor tissue will be collected from the surgical specimen.

Blood test

stool collection OTHER

In cohort B: Stool sample n°1 collected before surgery. Stool sample n°2 collected 1 month after surgery

Blood test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (3)

CHU de Besançon

Besançon, France

RECRUITING

Hôpital Nord-Franche-Comté

Montbéliard, France

NOT YET RECRUITING

Centre Hospitalier Intercommunal de Haute-Saône

Vesoul, France

NOT YET RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Christophe BORG, Pr

CONTACT

+33381668166; christophe.borg@efs.sante.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: February 23, 2021
• Study Start: March 30, 2021
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2032
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

FR (3)