Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-01-03 @ 6:41 PM
Study NCT ID:
NCT03289260
Status:
UNKNOWN
Last Update Posted:
2020-09-23
First Post:
2017-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003218', 'term': 'Condylomata Acuminata'}], 'ancestors': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'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': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077271', 'term': 'Imiquimod'}, {'id': 'D003972', 'term': 'Diathermy'}], 'ancestors': [{'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006979', 'term': 'Hyperthermia, Induced'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-22', 'studyFirstSubmitDate': '2017-09-19', 'studyFirstSubmitQcDate': '2017-09-19', 'lastUpdatePostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in recurrence rates between the two arms', 'timeFrame': '12 months', 'description': 'Recurrence is evaluated by clinical examination (proctoscopy)'}], 'secondaryOutcomes': [{'measure': 'CD4 (cluster of differentiation 4) cell count', 'timeFrame': '12 months', 'description': 'Influence of CD4 cell count in the subgroup of HIV positive patients'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Condylomata acuminata, Fulguration, Imiquimod'], 'conditions': ['Anogenital Human Papillomavirus Infection', 'Condyloma Anal']}, 'descriptionModule': {'briefSummary': 'AdAM is a prospective, randomized, controlled, double-blinded, monocentric trial in patients receiving surgical therapy due to anal HPV infection.\n\nAim of the study is to evaluate efficacy of combination therapy (surgical therapy + topical Imiquimod-therapy). It is planned to include 200 patients.\n\n100 patients receive surgical therapy+ topical Imiquimod therapy, 100 patients receive surgical therapy + topical Placebo therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to understand and willingness to sign and date a written consent document\n* Male and female patients \\>= 18 years of age\n* Negative urine/serum pregnancy test\n* Indication for surgical therapy of anal HPV lesions\n\nExclusion Criteria:\n\n* Participation in another clinical study with experimental therapy\n* Diagnosis and therapy of HPV associated lesions in the last 12 months\n* Known intolerance of hypersensitivity to Imiquimod\n* Women who are pregnant of lactating'}, 'identificationModule': {'nctId': 'NCT03289260', 'acronym': 'AdAM', 'briefTitle': 'Adjuvant Anal Imiquimod Therapy in Anal HPV-lesions: AdAM-trial', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Adjuvant Imiquimod Therapy to Reduce Recurrence Rate in Patients After Surgical Therapy of Anal HPV (Human Papilloma Virus)-Lesions', 'orgStudyIdInfo': {'id': 'AdAM_2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional Arm', 'description': 'Imiquimod 5% cream therapy Fulguration', 'interventionNames': ['Drug: Imiquimod 5% cream', 'Procedure: Fulguration']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'description': 'Placebo cream therapy Fulguration', 'interventionNames': ['Drug: Placebo cream', 'Procedure: Fulguration']}], 'interventions': [{'name': 'Imiquimod 5% cream', 'type': 'DRUG', 'otherNames': ['Aldara'], 'description': 'Patients receive topical Imiquimod therapy for 12 weeks.', 'armGroupLabels': ['Interventional Arm']}, {'name': 'Placebo cream', 'type': 'DRUG', 'otherNames': ['Doritin'], 'description': 'Patients receive topical Doritin therapy for 12 weeks', 'armGroupLabels': ['Placebo Arm']}, {'name': 'Fulguration', 'type': 'PROCEDURE', 'description': 'Surgical Excision and Fulguration of condyloma', 'armGroupLabels': ['Interventional Arm', 'Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'state': 'Tyrol', 'country': 'Austria', 'facility': 'Visceral-, Transplant- and Thoracic Surgery', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Irmgard E Kronberger, MD', 'role': 'CONTACT', 'email': 'irmgard.kronberger@i-med.ac.at', 'phone': '0043512504', 'phoneExt': '80823'}, {'name': 'Sascha Czipin, MD', 'role': 'CONTACT', 'email': 'sascha.czipin@i-med.ac.at', 'phone': '0043512504', 'phoneExt': '82070'}], 'overallOfficials': [{'name': 'Dietmar Öfner-Velano, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital for Visceral, Transplant and Thoracic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Leading Consultent', 'investigatorFullName': 'Irmgard E Kronberger, MD', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}