Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-03 @ 6:47 PM
Study NCT ID:
NCT02137694
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2014-04-30', 'studyFirstSubmitQcDate': '2014-05-12', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Research for human Papillomavirus by vaginal auto-takings and urinary test', 'timeFrame': '6 months', 'description': 'Estimate the research for human Papillomavirus ( HPV) in the vaginal auto-takings ( APV) and urinary ( APU) test at women from 25 to 65 years old requiring a screening.'}], 'secondaryOutcomes': [{'measure': 'The global logistic of the study', 'timeFrame': '6 months', 'description': 'Estimate the practicability, the organization of the screening, the follow-up of the women at the Brest Hospital and at Landerneau Hospital'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Papillomavirus', 'Vaginal auto-takings', 'Urinary test'], 'conditions': ['Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test']}, 'descriptionModule': {'briefSummary': 'Auto-takings by APU and vaginal APV during the consultations for FCU in the department of gynecology-obstetrics (Group 1) according to an instructions for use proposed to the inclusive women, with consent; the same proposal, APU and APV, is made for other consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology, ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results transmitted to the women and to the doctors of consultation. In case of positive test (15 %), the patients are directed to a gynecologist. Confrontation with the cytological data when available (Group 1) .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All the 25-65-year-old women requiring a screening and seen in consultation of the departments targeted by the CHRU of Brest\n\nExclusion Criteria:\n\n* Women except age limit, refusal to participate, hysterectomy, pregnancy and post-therapeutic follow-up.'}, 'identificationModule': {'nctId': 'NCT02137694', 'acronym': 'PapU-APV', 'briefTitle': 'Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Comparison of the Urinary and Vaginal Auto-takings for the Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer.', 'orgStudyIdInfo': {'id': 'RB 13.161 PapU-APV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PapU-APV', 'description': 'No drug and no placebo will be used in this study. For the study participants, only their medical history data and vaginal auto-takings ( APV) and urinary will be collected.', 'interventionNames': ['Other: vaginal auto-takings and urinary test']}], 'interventions': [{'name': 'vaginal auto-takings and urinary test', 'type': 'OTHER', 'description': 'vaginal auto-takings and urinary test', 'armGroupLabels': ['PapU-APV']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'state': 'France', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '29800', 'city': 'Landerneau', 'state': 'France', 'country': 'France', 'facility': 'Hôpital Ferdinand Grall', 'geoPoint': {'lat': 48.4515, 'lon': -4.25175}}], 'overallOfficials': [{'name': 'Christopher PAYAN, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Brest'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}