Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT03018327
Status:
COMPLETED
Last Update Posted:
2018-01-19
First Post:
2017-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ano-genital Human Papillomavirus (HPV) Infection, Precancerous Lesions and Genital Warts Among Danish Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'HPV samples tested by Inno-lipa'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-18', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-11', 'lastUpdatePostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of ano-genital HPV infection, dysplasia and warts', 'timeFrame': '18 month', 'description': 'Prevalence of oral, penile, cervical and anal HPV infection, ano-genital dysplasia and warts'}], 'secondaryOutcomes': [{'measure': 'Risk factors for the development of ano-genital dysplasia and warts', 'timeFrame': '18 month', 'description': 'Identifying factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anogenital Dysplasia']}, 'referencesModule': {'references': [{'pmid': '35438132', 'type': 'DERIVED', 'citation': 'Larsen HK, Kjaer SK, Haedersdal M, Kjaer AK, Bonde JH, Sorensen SS, Thomsen LT. Anal Human Papillomavirus Infection in Kidney Transplant Recipients Compared With Immunocompetent Controls. Clin Infect Dis. 2022 Nov 30;75(11):1993-1999. doi: 10.1093/cid/ciac285.'}]}, 'descriptionModule': {'briefSummary': 'Transplant-related malignancies have emerged as one of the important complications after organ transplantation. Some studies have shown that transplant recipients have an increased risk of developing cancer, especially non-melanoma skin cancer. Because of iatrogenic immunosuppression in these patients, there is an increasing focus on human papillomavirus (HPV) related cancers.\n\nThe occurrence of HPV infection and ano-genital precancerous lesions and genital warts among Danish renal transplant recipients (RTRs) is not known. Relatively few controlled studies exist on the prevalence of ano-genital HPV infection, anal precancerous lesions and cervical precancerous lesions among RTRs.\n\nKnowledge about HPV infection and HPV-related ano-genital precancerous lesions in renal transplant recipients, together with identification of factors that play a role for development of anal and cervical precancerous lesions, is important for the possibility of early detection and treatment to prevent progression to ano-genital cancers. Cervical cytology has been used for decades to detect cervical intra-epithelial neoplasia (CIN), whereas high-resolution anoscopy is a newer modality for the detection of anal intra-epithelial neoplasia (AIN). International guidelines recommend annually screening against cervical cancer for female renal transplant recipients, but currently no recommendation exists on screening against anal cancer.\n\nAim: In a clinical study it is the aim to examine the prevalence of anal, penile, oral and cervical HPV infection as well as ano-genital dysplasia and ano-genital warts among 250 renal transplant recipients and an immunocompetent control group. Furthermore to identify factors associated with the development of AIN or CIN such as HPV type, viral load, duration of immunosuppression, and lifestyle factors such as sexual habits, reproductive history, smoking and alcohol habits, history of genital warts and other infections, and socio-economic variables.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will include 250 male and female renal transplant recipients in the case group. The patients will be recruited from "The Transplantation Clinic" at the Department of Dermato-venereology, Bispebjerg Hospital (BBH), where they are being followed for development of cutaneous (pre-)malignancies and from the Department of Nephrology at Rigshospital and Herlev Hospital, Denmark. In the control group we will include 250 immunocompetent individuals consisting of male and female patients coming for control of birthmarks at the Nevus Clinic or Non-melanoma skin cancer and precancer at BBH and patients having laser treatment for benign cutaneous lesions at BBH. The participants will be enrolled in the study after informed consent has been obtained.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\-\n\nCase group:\n\n1. Renal transplant recipients men and women ≥ 18 years of age\n2. ≥ 6 months posttransplantation\n3. Stabile immunosuppressive regime\n4. No signs of acute rejection og the transplant\n\nControl group:\n\n1\\. Health men and women ≥18years of age from the Nevus clinic, Laser clinic and non-melanoma skin cancer clinic, Bispebjerg Hospital, Copenhagen\n\nExclusion Criteria:\n\n* Case group:\n\n 1. Other known immunosuppression\n\n Both case- og control group:\n 2. Previous HPV vaccination\n 3. Previous total hysterectomy\n 4. Inflammatory bowel disease\n 5. HIV infection'}, 'identificationModule': {'nctId': 'NCT03018327', 'briefTitle': 'Ano-genital Human Papillomavirus (HPV) Infection, Precancerous Lesions and Genital Warts Among Danish Renal Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Ano-genital Human Papillomavirus (HPV) Infection, Genital Warts, Precancerous Lesions and Cancer Among Danish Renal Transplant Recipients', 'orgStudyIdInfo': {'id': 'H-15014510'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case group', 'description': '250 Renal Transplant Recipients; 125 women and 125 men'}, {'label': 'Control group', 'description': '250 healthy controls; 125 women and 125 men'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Dermato-venereology, Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Helle Kiellberg Larsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermato-venereology, Bispebjerg Hospital, 2400 Copenhagen, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Cancer Society', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff specialist', 'investigatorFullName': 'Helle Kiellberg Larsen', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}