Genital HPV Infections Before and After Renal Transplantation

The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females 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.

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus Infections

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 Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6500 HB
    • Radboud University Nijmegen Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Women, renal disease, transplantation; Women with end-stage renal disease, whose eligibility for renal transplantation is assessed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease	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.	6 months before and 6 months after renal transplantation

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medical Center Nijmegen
• Collaborators: Dutch Kidney Foundation
• Investigators: Principal Investigator: Joanne A de Hullu, MD, PhD, University Medical Centre Nijmegen

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): October 1, 2015
• Study Completion (ACTUAL): January 1, 2016

Study Registration Dates

• First Submitted: August 23, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (ESTIMATE): October 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Human Papillomavirus; Renal transplantation
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Infections; Communicable Diseases; Papillomavirus Infections
• Other Study ID Numbers: NL38266.091.11