Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 11:34 PM
Study NCT ID:
NCT05193669
Status:
UNKNOWN
Last Update Posted:
2023-02-08
First Post:
2021-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of Molecular Triage in HR-HPV Positive Women
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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Cervical swab, cervical biopsies'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23941}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-04', 'studyFirstSubmitDate': '2021-12-11', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the index triage test: Pap-test', 'timeFrame': 'Baseline', 'description': 'Sensitivity of the index triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage and relative sensitivity (index vs comparator)'}, {'measure': 'Sensitivity of the index and comparator triage test: HPV molecular test', 'timeFrame': 'Baseline', 'description': 'Sensitivity of the index and comparator triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage + delayed triage; and relative sensitivity (index vs comparator).'}, {'measure': 'Specificity of the index and comparator triage test', 'timeFrame': 'Month 12', 'description': 'Specificity of the index and comparator triage test(s) performed at the time of reflex testing for \\<CIN2 considered at the time of reflex triage accepting negative colposcopy at the time of reflex testing and double negative index triage testing (reflex and delayed) as an acceptable proxy for \\<CIN2 and relative specificity for \\<CIN2 (index vs comparator).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['molecular HPV test', 'Pap-test', 'Triage'], 'conditions': ['Cervical Carcinoma']}, 'descriptionModule': {'briefSummary': 'Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '25 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Women accessing the HPV-based screening programme 'Prevenzione Serena', for primary screening, supported by a comprehensive follow-up registry.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women participating in a cervical cancer screening program using an HPV assay as primary screening test\n* positivity to hrHPV;\n* written informed consent given.\n\nExclusion Criteria:\n\n* total hysterectomy;\n* diagnosis of CIN2+ in the last two years;\n* hrHPV negative or inadequate.'}, 'identificationModule': {'nctId': 'NCT05193669', 'acronym': 'VALTRIHP', 'briefTitle': 'Clinical Validation of Molecular Triage in HR-HPV Positive Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hiantis Srl'}, 'officialTitle': 'VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus', 'orgStudyIdInfo': {'id': 'WP7-HPVONC'}}, 'contactsLocationsModule': {'locations': [{'zip': '10123', 'city': 'Torino', 'country': 'Italy', 'facility': 'AOU Città della Salute e della Scienza di Torino S.S.D. Epidemiologia, Screening- CPO', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'overallOfficials': [{'name': 'Paola Armaroli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AOU Città della Salute e della Scienza di Torino, Itay'}, {'name': 'Marc Arbyn, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sciensano - Brussels, Belgium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hiantis Srl', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}, {'name': 'Sciensano', 'class': 'OTHER_GOV'}, {'name': 'University of Milano Bicocca', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}