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

Обзор

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.

Вмешательства

• Диагностический тест 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
• Другое Tumor tissue
  In each cohort, tumor tissue will be collected from the surgical specimen.
• Другое stool collection
  In cohort B: Stool sample n°1 collected before surgery. Stool sample n°2 collected 1 month after surgery

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 3 центра

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

Идентификаторы

NCT: NCT04767568 · 2020/539

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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