Trial record 2 of 59 for:    Open Studies | "Papillomavirus Infections"

Genital HPV Infections Before and After Renal Transplantation

This study is currently recruiting participants.
Verified October 2012 by University Medical Center Nijmegen
Sponsor:
Collaborator:
Dutch Kidney Foundation
Information provided by (Responsible Party):
Joanne A. de Hullu, MD, PhD, University Medical Center Nijmegen
ClinicalTrials.gov Identifier:
NCT01717443
First received: August 23, 2012
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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.


Condition
Human Papillomavirus Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation

Resource links provided by NLM:


Further study details as provided by University Medical Center Nijmegen:

Primary Outcome Measures:
  • Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease [ Time Frame: 6 months before and 6 months after renal transplantation ] [ Designated as safety issue: No ]
    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:
  • Incidence of genital HPV infection before and after renal transplantation [ Time Frame: Assessed every 3 months for 2 years ] [ Designated as safety issue: No ]
  • Genotype of the HPV infection per time point [ Time Frame: Assessed every 3 months for 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women, renal disease, transplantation
Women with end-stage renal disease, whose eligibility for renal transplantation is assessed

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717443

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Netherlands, 6500 HB
Contact: Joanne de Hullu, PhD    +31-24-3618777    j.dehullu@obgyn.umcn.nl   
Sub-Investigator: Floor Hinten, MD         
Sponsors and Collaborators
University Medical Center Nijmegen
Dutch Kidney Foundation
Investigators
Principal Investigator: Joanne A de Hullu, MD, PhD University Medical Centre Nijmegen
  More Information

No publications provided

Responsible Party: Joanne A. de Hullu, MD, PhD, MD, PhD, University Medical Center Nijmegen
ClinicalTrials.gov Identifier: NCT01717443     History of Changes
Other Study ID Numbers: NL38266.091.11
Study First Received: August 23, 2012
Last Updated: October 25, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by University Medical Center Nijmegen:
Human Papillomavirus
Renal transplantation

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Neoplasms
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014