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

  • STATUS
    Recruiting
  • End date
    Sep 15, 2027
  • participants needed
    400
  • sponsor
    Centre Hospitalier Universitaire de Besancon
Updated on 15 June 2021

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.

Details
Condition Colorectal Cancer, Rectal disorder, colorectal neoplasm, colorectal cancers, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment Blood sample, Tumor Tissue
Clinical Study IdentifierNCT04767568
SponsorCentre Hospitalier Universitaire de Besancon
Last Modified on15 June 2021

Eligibility

Yes No Not Sure

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
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