Clinical trial NCT01717443: Genital HPV Infections Before and After Renal Transplantation
Official title: The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papillomavirus Infections
Keywords: Human Papillomavirus
Renal transplantation
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
Collaborators: name: Dutch Kidney Foundation
First posted: 2012-10-30
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of women above 18 years of age with end stage renal disease who are registered for renal transplantation

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Female sex;
* Age ≥ 18 years at start of the study;
* Eligible for renal transplantation;
* Operation at the Radboud University Nijmegen Medical Centre;
* Signed informed consent;
* Mentally capable to understand and comprehend the study and its implications;
* Sufficient knowledge of the Dutch language to read, fully understand and complete the Questionnaire.

Exclusion Criteria:

* Patient not willing to sign and/or return the informed consent form;
* Patient refusing additional treatment in case of abnormal findings at the first visit;
* Patient being pregnant, or within a period of 3 months after delivery;
* Patient being within a period of 3 months after miscarriage.

Primary outcomes:
measure: Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease
timeFrame: 6 months before and 6 months after renal transplantation
Secondary outcomes:
measure: Incidence of genital HPV infection before and after renal transplantation
timeFrame: Assessed every 3 months for 2 years
measure: Genotype of the HPV infection per time point
timeFrame: Assessed every 3 months for 2 years
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: University Medical Centre Nijmegen
name: Joanne A de Hullu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: