Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening (PREDICT-IRFC)

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: Blood sample; Other: Tumor tissue; Other: stool collection

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christophe BORG, Pr; Phone Number: +33381668166; Email: christophe.borg@efs.sante.fr

Study Locations

• France
  • Besançon, France
    • Recruiting
    • CHU de Besancon
    • Contact: Christophe BORG
  • Montbéliard, France
    • Not yet recruiting
    • Hôpital Nord-Franche-Comté
  • Vesoul, France
    • Not yet recruiting
    • Centre Hospitalier Intercommunal de Haute-Saône

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Diagnostic test: Blood sample; 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; Other: Tumor tissue; In each cohort, tumor tissue will be collected from the surgical specimen.; Other: stool collection; In cohort B: Stool sample n°1 collected before surgery. Stool sample n°2 collected 1 month after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: early detection; blood test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2020/539

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No