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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03018327
Date of registration: 10/01/2017
Prospective Registration: No
Primary sponsor: Bispebjerg Hospital
Public title: Ano-genital Human Papillomavirus (HPV) Infection, Precancerous Lesions and Genital Warts Among Danish Renal Transplant Recipients
Scientific title: Ano-genital Human Papillomavirus (HPV) Infection, Genital Warts, Precancerous Lesions and Cancer Among Danish Renal Transplant Recipients
Date of first enrolment: January 7, 2016
Target sample size: 500
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03018327
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Denmark
Contacts
Name:     Helle Kiellberg Larsen, MD
Address: 
Telephone:
Email:
Affiliation:  Department of Dermato-venereology, Bispebjerg Hospital, 2400 Copenhagen, Denmark
Key inclusion & exclusion criteria

Inclusion Criteria:

-

Case group:

1. Renal transplant recipients men and women = 18 years of age

2. = 6 months posttransplantation

3. Stabile immunosuppressive regime

4. No signs of acute rejection og the transplant

Control group:

1. Health men and women =18years of age from the Nevus clinic, Laser clinic and
non-melanoma skin cancer clinic, Bispebjerg Hospital, Copenhagen

Exclusion Criteria:

- Case group:

1. Other known immunosuppression

Both case- og control group:

2. Previous HPV vaccination

3. Previous total hysterectomy

4. Inflammatory bowel disease

5. HIV infection



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Anogenital Dysplasia
Intervention(s)
Primary Outcome(s)
Prevalence of ano-genital HPV infection, dysplasia and warts [Time Frame: 18 month]
Secondary Outcome(s)
Risk factors for the development of ano-genital dysplasia and warts [Time Frame: 18 month]
Secondary ID(s)
H-15014510
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Danish Cancer Society
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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