RecruitingNot ApplicableNCT04767568

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


Sponsor

Centre Hospitalier Universitaire de Besancon

Enrollment

400 participants

Start Date

Mar 30, 2021

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a blood test that detects cancer DNA circulating in the bloodstream to see if it can help detect colorectal cancer earlier or more accurately, compared to standard methods like colonoscopy. **You may be eligible if...** - You are 18 years or older - You fall into one of two groups: (A) you had a positive stool-based screening test or rectal bleeding and are being evaluated for colorectal cancer, OR (B) you have already been diagnosed with colorectal adenocarcinoma by pathology and are scheduled for surgery - You have signed informed consent **You may NOT be eligible if...** - You are under 18 years old - You do not fall into either screening or diagnosis cohort - You have not given consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBlood 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

OTHERTumor tissue

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

OTHERstool collection

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


Locations(3)

CHU de Besançon

Besançon, France

Hôpital Nord-Franche-Comté

Montbéliard, France

Centre Hospitalier Intercommunal de Haute-Saône

Vesoul, France

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NCT04767568