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临床试验/NCT01717443
NCT01717443已完成不适用

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

University Medical Center Nijmegen1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease

时间窗: 6 months before and 6 months after renal transplantation

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.

次要结局

  • 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)

研究者

发起方
University Medical Center Nijmegen
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne A. de Hullu, MD, PhD

MD, PhD

University Medical Center Nijmegen

研究点 (1)

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