Genital HPV Infections Before and After Renal Transplantation

NCT01717443 | Completed

• 1 other identifier: NL38266.091.11
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus Infections

Keywords

Human Papillomavirus; Renal transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

Women, renal disease, transplantation

Women with end-stage renal disease, whose eligibility for renal transplantation is assessed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Nijmegen: lead
• Dutch Kidney Foundation: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joanne A de Hullu, MD, PhD

  University Medical Centre Nijmegen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: October 30, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: January 1, 2016
• Last Updated: October 25, 2016

Record last verified: 2016-10

Locations

NL (1)