Genital HPV Infections Before and After Renal Transplantation

University Medical Center Nijmegen

Status: Completed

Conditions: Human Papillomavirus Infections

Study type: Observational

Funder types: Other

Identifiers

NCT01717443

NL38266.091.11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

65 participants in 1 patient group

Women, renal disease, transplantation

Description:

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