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

Overview

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.

Interventions

• 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

Primary outcome measures

• sensitivity and specificity of a blood test [Time frame: 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. [Time frame: one month after surgery, an average of 6 months from inclusion]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 3 centers

• CHU de Besançon — Besançon
• Hôpital Nord-Franche-Comté — Montbéliard
• Centre Hospitalier Intercommunal de Haute-Saône — Vesoul

Identifiers

NCT: NCT04767568 · 2020/539

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗