Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening
NCT ID: NCT04767568
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2021-03-30
2028-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
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
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Not ability to comply with the study protocol, in the Investigator's judgment
* pregnant woman
* Patient in the period of exclusion of another study
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Locations
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CHU de Besançon
Besançon, , France
Hôpital Nord-Franche-Comté
Montbéliard, , France
Centre Hospitalier Intercommunal de Haute-Saône
Vesoul, , France
Countries
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Central Contacts
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Other Identifiers
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2020/539
Identifier Type: -
Identifier Source: org_study_id