Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2026-02-03 @ 9:04 AM
Study NCT ID:
NCT03082950
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2017-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HPV Infections, Cancer of the Vulva and Therapeutical Success
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tumor tissue samples are analyzed according to their hpv status'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2017-03-12', 'studyFirstSubmitQcDate': '2017-03-16', 'lastUpdatePostDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of hpv infections among pations suffering from vulvar cancer and preinvasive lesions', 'timeFrame': '15yrs'}], 'secondaryOutcomes': [{'measure': 'disease free survival among the groups', 'timeFrame': '15yrs'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hpv prevalence', 'recurrence rate', 'survival'], 'conditions': ['HPV', 'Human Papilloma Virus']}, 'referencesModule': {'references': [{'pmid': '19550210', 'type': 'BACKGROUND', 'citation': 'Massad LS, Jeronimo J, Katki HA, Schiffman M; National Institutes of Health/American Society for Colposcopy and Cervical Pathology Research Group. The accuracy of colposcopic grading for detection of high-grade cervical intraepithelial neoplasia. J Low Genit Tract Dis. 2009 Jul;13(3):137-44. doi: 10.1097/LGT.0b013e31819308d4.'}, {'pmid': '23710698', 'type': 'BACKGROUND', 'citation': 'Sri T, Merideth MA, Pulanic TK, Childs R, Stratton P. Human papillomavirus reactivation following treatment of genital graft-versus-host disease. Transpl Infect Dis. 2013 Aug;15(4):E148-51. doi: 10.1111/tid.12098. Epub 2013 May 28.'}, {'pmid': '21289941', 'type': 'BACKGROUND', 'citation': 'Nocon M, Mittendorf T, Roll S, Greiner W, Willich SN, von der Schulenburg JM. Review on the medical and health economic evidence for an inclusion of colposcopy in primary screening programs for cervical cancer. GMS Health Technol Assess. 2007 Aug 10;3:Doc07.'}]}, 'descriptionModule': {'briefSummary': 'HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.', 'detailedDescription': 'HPV infections may be responsible for different types of cancer in females. Primary Goal of the study was to identify the prevalence of an hpv affiliation in retrospective-prospective analysed cohort of patients who suffer from vulvar cancer and their preinvasive lesions.\n\nAfter having retrospectively identified patients with vulvar cancer incl. their preinvasive lesions in the clinical registry the hpv status of the samples is prospectively analyzed using a new multiplex pcr Array. Two Groups are build: patients with hpv associated vulvar cancer and patients with non-hpv associated vulvar cancer.\n\nThen, the rate of patients who respond to radiotherapy within the Groups is analyzed by building Kaplan meier plots according to the patients survival and recurrence rate.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pts. who suffer from vulvar cancer and their preinvasive lesions who were treated in luebeck University medical Center over a 15 year period', 'genderDescription': 'female the illness only affiliates females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pts. who suffer from vulvar cancer and their preinvasive lesions\n* positive informed consent\n* complete set of data\n* Treatment in luebeck university\n\nExclusion Criteria:\n\n* opposite of above'}, 'identificationModule': {'nctId': 'NCT03082950', 'briefTitle': 'HPV Infections, Cancer of the Vulva and Therapeutical Success', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'Influence of Hpv Infections on Therapeutical Outcome of Patients Suffering From Vulvar Cancer and Ist Preinvasive Lesions', 'orgStudyIdInfo': {'id': 'HL-15-220'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions', 'interventionNames': ['Diagnostic Test: polymerase chain reaction']}, {'label': '2', 'description': 'non-human papilloma Virus (hpv) associated vulvar cancer incl. preinvasive lesions', 'interventionNames': ['Diagnostic Test: polymerase chain reaction']}], 'interventions': [{'name': 'polymerase chain reaction', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['EUROARRAY'], 'description': 'PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-23538', 'city': 'Lübeck', 'state': 'Schleswig-Holstein', 'country': 'Germany', 'facility': 'Luebeck University, Department for obstetrics and gynecology', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Daniel Beyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Westpfalz-Klinikum'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'collaborators': [{'name': 'EUROIMMUN Medizinische Labordiagnostika AG', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University of Luebeck', 'investigatorFullName': 'Daniel Alexander Beyer', 'investigatorAffiliation': 'University of Luebeck'}}}}