Genital HPV Infections Before and After Renal Transplantation

Completed

• Conditions: Human Papillomavirus Infections

• Registration Number: NCT01717443
• Lead Sponsor: University Medical Center Nijmegen

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-30
• Primary Completion: 2015-10
• Study Completion: 2016-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease	6 months before and 6 months after renal transplantation	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of genital HPV infection before and after renal transplantation	Assessed every 3 months for 2 years
Genotype of the HPV infection per time point	Assessed every 3 months for 2 years

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands