Genital HPV Infections Before and After Renal Transplantation
The purpose of this study is to examine the prevalence, incidence and genotype of anogenital HPV infections in women before and after renal transplantation. With this information the investigators can determine the value of vaccination in patients waiting for renal transplantation in the future.
Human Papillomavirus Infections
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation|
- Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease [ Time Frame: 6 months before and 6 months after renal transplantation ] [ Designated as safety issue: No ]The difference between post-transplantation prevalence (two HPV tests in 6 months after transplantation)and pre-transplantation prevalence (two HPV tests in 6 months before transplantation) will be compared.
- Incidence of genital HPV infection before and after renal transplantation [ Time Frame: Assessed every 3 months for 2 years ] [ Designated as safety issue: No ]
- Genotype of the HPV infection per time point [ Time Frame: Assessed every 3 months for 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Women, renal disease, transplantation
Women with end-stage renal disease, whose eligibility for renal transplantation is assessed
Each year about 800 renal transplantations are performed in the Netherlands. The current immunosuppressive strategies have led to a 1-year patient and graft survival of more than 90%. This high survival rate urges medical specialists to pay increasing attention to the long‐term side effects of immunosuppressive medication, such as virus‐associated cancers. An example of an oncogenic virus is the high risk Human Papillomavirus (hrHPV) which is related to (pre)malignancies of the anogenital tract e.g. cervix, vulva and anus. These malignancies are among the most common malignancies in renal transplant recipients (RTRs). The incidence of hrHPV‐related cervical and vulvar malignancies is increased up to a 100‐fold in RTRs compared to the general population. There is limited literature on the exact behaviour of HPV infection related anogenital (pre)malignancies in RTRs. A part of these (pre)malignancies are probably already present at the time of transplantation while others develop in the years after transplantation. With gynaecological examination the investigators can diagnose anogenital (pre)malignancies before transplantation so treatment, if necessary, can commence before transplantation. Knowledge about HPV status before and after transplantation gives insight in the natural course of the HPV infection in this group of patients and with this information the investigators can determine the value of vaccination in patients waiting for renal transplantation in the future.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717443
|Radboud University Nijmegen Medical Centre||Recruiting|
|Nijmegen, Netherlands, 6500 HB|
|Contact: Joanne de Hullu, PhD +31-24-3618777 firstname.lastname@example.org|
|Sub-Investigator: Floor Hinten, MD|
|Principal Investigator:||Joanne A de Hullu, MD, PhD||University Medical Centre Nijmegen|