Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2025-12-29 @ 6:12 PM
Study NCT ID:
NCT04767568
Status:
RECRUITING
Last Update Posted:
2024-12-27
First Post:
2020-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2020-12-03', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity and specificity of a blood test', 'timeFrame': 'one month after surgery, an average of 6 months from inclusion'}, {'measure': '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.', 'timeFrame': 'one month after surgery, an average of 6 months from inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood test', 'early detection'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nEarly 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.\n\nIf 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.\n\nRecently, with the covid-19 epidemic, the investigators were faced with an extension of the delays for colonoscopies which led to delays in patient care.\n\nTo prevent this, they propose to develop a blood test that would allow rapid identification of patients with colorectal cancer, requiring rapid management.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged more than18 years\n* 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\n* Signed and dated informed consent\n* Patient affiliated to or beneficiary of French social security system.\n\nExclusion Criteria:\n\n* Vulnerable persons according to the law (minors, adults under protection, persons deprived of liberty ...)\n* Not ability to comply with the study protocol, in the Investigator's judgment\n* pregnant woman\n* Patient in the period of exclusion of another study"}, 'identificationModule': {'nctId': 'NCT04767568', 'acronym': 'PREDICT-IRFC', 'briefTitle': 'Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Exploratory Study of the Relevance of a Blood Test in the Management of Patients in the Context of Colorectal Cancer Screening', 'orgStudyIdInfo': {'id': '2020/539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood test', 'description': '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\n\nIn cohort B: 200 patients who have already performed colonoscopy candidates for surgery on their colorectal tumor', 'interventionNames': ['Diagnostic Test: Blood sample', 'Other: Tumor tissue', 'Other: stool collection']}], 'interventions': [{'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nIn cohort B: Blood sample n°1 (PBMC, plasma, ctDNA) collected before surgery. Blood sample n°2 (PBMC, plasma, ctDNA) collected 1 month after surgery', 'armGroupLabels': ['Blood test']}, {'name': 'Tumor tissue', 'type': 'OTHER', 'description': 'In each cohort, tumor tissue will be collected from the surgical specimen.', 'armGroupLabels': ['Blood test']}, {'name': 'stool collection', 'type': 'OTHER', 'description': 'In cohort B: Stool sample n°1 collected before surgery. Stool sample n°2 collected 1 month after surgery', 'armGroupLabels': ['Blood test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Montbéliard', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'facility': 'Hôpital Nord-Franche-Comté', 'geoPoint': {'lat': 47.50957, 'lon': 6.79823}}, {'city': 'Vesoul', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'facility': 'Centre Hospitalier Intercommunal de Haute-Saône', 'geoPoint': {'lat': 47.62604, 'lon': 6.14251}}], 'centralContacts': [{'name': 'Christophe BORG, Pr', 'role': 'CONTACT', 'email': 'christophe.borg@efs.sante.fr', 'phone': '+33381668166'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}