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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01717443
Study type Observational
Source University Medical Center Nijmegen
Contact
Status Completed
Phase N/A
Start date February 2012
Completion date January 2016

See also
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Completed NCT02009800 - ICI-VPH: Impact of HPV Immunisation Schedules Against HPV Phase 3
Completed NCT01077856 - GARDASIL™ Vaccine Impact in Population Study (V501-033)