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

Colorectal Cancer Clinical Trial

— PREDICT-IRFC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04767568
• Other study ID #: 2020/539
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: September 2028

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Christophe BORG, Pr
• Phone: +33381668166
• Email: christophe.borg[@]efs.sante.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2028
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CHU de Besançon	Besançon
France	Hôpital Nord-Franche-Comté	Montbéliard
France	Centre Hospitalier Intercommunal de Haute-Saône	Vesoul

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity and specificity of a blood test		one month after surgery, an average of 6 months from inclusion
Primary	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