Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-01-11 @ 6:03 AM
Study NCT ID:
NCT03383367
Status:
UNKNOWN
Last Update Posted:
2017-12-26
First Post:
2017-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A prospective interventional study to evaluate the impact of a reminder sent by the Adémas-69 organization to improve coloscopy surveillance and compliance with recommendations for high risk of colorectal cancer people.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 33000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-22', 'studyFirstSubmitDate': '2017-12-01', 'studyFirstSubmitQcDate': '2017-12-22', 'lastUpdatePostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'participation rate at future colonoscopy', 'timeFrame': 'At time of evaluation we will check the colonoscopy realized at six months after sending the letter at the person', 'description': 'participation rate at future colonoscopy that is the number of patient that really have colonoscopy among the patients who receive a reminder letter The systematic registry of colonoscopies will permit to assess if a patient performs it.'}], 'secondaryOutcomes': [{'measure': 'description of lesions severities found at surveillance colonoscopy after letter reminder', 'timeFrame': "Lesions'severity will be evaluated at 6, 9 or 15 months following the reminder sent according to the colonoscopist's recommendation (1,3 or 5 years after reference exams). By the way of systematic registration. .", 'description': 'We will assess the severity of the lesions found at colonoscopy performed at th right time : level of dysplasia ; size ; histologic characteristics ; numbers of adenoma.'}, {'measure': 'Cost-utility analysis of the reminder letter for surveillance colonoscopy', 'timeFrame': "Lesions'severity will be evaluated at 6, 9 or 15 months following the reminder sent according to the colonoscopist's recommendation (1,3 or 5 years after reference exams). The costs will be registered at the same time.", 'description': "French Health Insurance is the point of vue selected for the evaluation. It's a cost-utility analysis. A Markov model will be performed. The data will proceed from litterature and from data registration during the study. A complementary study will be performed specifically if needed.\n\nFor the Markov model the data needed : neoplasia, adenocarcinoma, advanced adenoma, reminders costs, treatments costs, examinations costs, organization costs."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mass screening', 'colonoscopy surveillance', 'high risk patients'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'France is one of the European countries where the incidence of colorectal cancer is the highest among cancers for both sexes. Fecal occult blood screening has been implemented since 2008. However, this screening excludes high risk people who have a 10 to 30 % risk of developing a CRC during their lifetime. Colonoscopy follow up of these persons is not organized, and it is up to the attending physician to recall the date of the surveillance colonoscopy. This results in a poor compliance with the recommendations by these people. A postal reminder of the surveillance colonoscopies sent by The French screening organizations to the patients should increase adherence to follow-up recommendations. The colorectal cancer screening organizations will collects from the hepatogastroenterologists (HGE) informations on colonoscopies of people more than 50 years old who live in the Rhone. These informations will allow to send a reminder 3 months before the date recommended by the HGE. Participation rate and timeliness will be assessed, as well as the severity of the lesions found. A medico-economic analysis will also be carried out.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* people aged 50 years or more ;\n* at high risk of colorectal cancer ;\n* living in Rhône administrative departement or Metropolitan Lyon\n\nExclusion Criteria:\n\n* person with chronic inflammatory bowel disease\n* colorectal cancer in diagnosis or treatment period'}, 'identificationModule': {'nctId': 'NCT03383367', 'acronym': 'Tempo-colo', 'briefTitle': 'Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Association pour le Dépistage Organisé des Cancers dans le Rhône'}, 'officialTitle': 'Extending the Prerogatives of Colorectal Cancer Screening French Organizations to the Follow-up After Colonoscopy of Patients Aged 50 or More: Pilot Study in the Rhône Administrative Department', 'orgStudyIdInfo': {'id': '2016-A01710-51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tempo Colo', 'interventionNames': ['Behavioral: Tempo Colo']}], 'interventions': [{'name': 'Tempo Colo', 'type': 'BEHAVIORAL', 'description': 'Reminder letter for people at high risk of colorectal cancer.', 'armGroupLabels': ['Tempo Colo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69005', 'city': 'Lyon', 'state': 'Rhône', 'country': 'France', 'facility': 'Adémas-69', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Association pour le Dépistage Organisé des Cancers dans le Rhône', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}