Genital HPV Infections Before and After Renal Transplantation

Human Papillomavirus Infections Clinical Trial

Official title:

The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717443
• Other study ID #: NL38266.091.11
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: October 24, 2016
• Start date: February 2012
• Est. completion date: January 2016

Study information

• Verified date: October 2016
• Source: University Medical Center Nijmegen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 2016
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Communicable Diseases
• Human Papillomavirus Infections
• Infection
• Papillomavirus Infections

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Nijmegen	Dutch Kidney Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of genital HPV infection before and after renal transplantation		Assessed every 3 months for 2 years	No
Secondary	Genotype of the HPV infection per time point		Assessed every 3 months for 2 years	No