Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-19 @ 1:29 PM
Study NCT ID:
NCT06527456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-29
First Post:
2023-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2024-07-25', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'screening participation rate', 'timeFrame': '12 month', 'description': 'percentage of patients who had a screening Cervical Sample (cytology or HPV test within a timeframe satisfying the HAS recommendations according to age) among patients eligible for screening aged 25 to 65 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'In France, cervical cancer is the 12th most common female cancer with nearly 3,000 new cases per year.\n\nSince 2018, a national Organized Cervical Cancer Screening program (DOCCU) has been set up and concerns all asymptomatic women aged 25 to 65.\n\nThis program, managed by the Regional Cancer Screening Coordination Centers (CRCDC), invites women who have not taken a sample within the recommended time frame to consult for screening. However, only 59% of patients participated.\n\nThe intervention of the general practitioner, an essential player in prevention, could allow for better awareness.\n\nThe objective of the INDIGO study is to evaluate the effectiveness of the intervention of a general practitioner on the participation rate in the DOCCU of patients who are not up to date with their screening.', 'detailedDescription': 'This is a cluster-randomized trial. Randomization will be performed at the GP practice level to limit the potential contamination bias between doctors within the same practice. GP practices will be randomized either to the \'usual practice\' arm or the \'intervention\' arm."\n\nIf they are in the "intervention" group, they or one of the professionals in their team will contact the patient (phone call, SMS, email, etc.), to encourage her to make an appointment to carry out the screening. Contact arrangements are left to the discretion of each general practitioner..\n\nIf they are in the "Usual practice" group, they will use their usual practices to encourage screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Woman aged 25 to 65 living in Ile-De-France\n* Eligible for DOCCU (not hysterectomized, not followed for a pre-cancerous or cancerous lesion of the cervix)\n* Having declared the investigating general practitioner as a treating physician (MT) and whose MT practices in the territory of a CPTS in the UPEC area\n* Affiliate to a social security scheme or beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Patient already included in a study on DOCCU\n* Patient excluded from organized screening (cervical cancer, hysterectomy).\n* Patient's opposition to participating in the study"}, 'identificationModule': {'nctId': 'NCT06527456', 'acronym': 'INDIGO', 'briefTitle': "Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': "Intervention With General Practitioners to Improve Women's Participation in Cervical Cancer Screening", 'orgStudyIdInfo': {'id': 'INDIGO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'usual practice', 'description': 'the doctor will use their usual practices to encourage screening.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'the general practitioner or one of the professionals on their team will contact the patient (phone call, SMS, email, etc.), to encourage them to make an appointment to carry out the screening', 'interventionNames': ['Other: participation of the general practitioner']}], 'interventions': [{'name': 'participation of the general practitioner', 'type': 'OTHER', 'description': 'participation of the general practitioner in encouraging cervical cancer screening', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Emilie FERRAT', 'role': 'CONTACT', 'email': 'emilie.ferrat@u-pec.fr', 'phone': '0633085225'}, {'name': 'Camille JUNG', 'role': 'CONTACT', 'email': 'camille.jung@chicreteil.fr', 'phone': '01.57.02.22.68'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}