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临床试验/NCT02845739
NCT02845739已完成不适用

Study of the Distribution of Genotypes of HPV at the Ano-genital Area and Peripheral Humoral Immune Response Before and After Kidney Transplantation

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 58 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
58
主要终点
Prevalence of genital HPV infection before and after kidney transplantation in man and women

研究概览

简要总结

The main goal of project is to study the distribution of HPV genotypes in the anogenital area and peripheral humoral immune responses HPV (total and neutralizing Ab) before and after renal transplantation. Furthermore, the investigators wish (i) establish whether there is a correlation between HPV infection and HPV immune response before and after transplantation, and (ii) determine whether there is a link between HPV infection and immunosuppression.

详细描述

Kidney transplant patients, iatrogenic immunosuppression established, essential to limit the transplant. Kidney transplant patients, iatrogenic immunosuppression established, essential to limit the transplant rejection, exposes patients to an increased risk of infections, including human papillomavirus (HPV).

These patients thus constitute a population at risk of developing cancers associated with HPV. Indeed, a recent meta-analysis indicated that the standardized incidence ratio for cancers associated with HPV increases dramatically in kidney transplant: SIR of 2.13 (95% CI 1.37 to 3.30) for the cervical, RIS 22.76 (95% CI 15.8 to 32.7) for the vulva and vagina, RIS 15.8 (95% CI 5.79 to 34.40) for the penis, RIS 4.85 (95% CI 1.36 to 17.3) and RIS to the anus of 3.23 (95% CI 2.40 to 4.35) for the oral cavity and pharynx. In fact, transplant patients are subject to increased surveillance to detect the onset and / or progression of lesions (pre) cancerous, especially anogenital level. Data on HPV infection in the genital area of kidney transplant patients are few and concern cohorts with a modest number of subjects. Indeed, it is difficult to estimate the prevalence of infection and know precisely genotypes of HPV present in anogenital level. Similarly, some studies report the presence of anti-HPV antibodies in transplant patients.

The main goal of project is to study the distribution of HPV genotypes in the anogenital area and peripheral humoral immune responses HPV (total and neutralizing Ab) before and after renal transplantation. Furthermore, the investigators wish (i) establish whether there is a correlation between HPV infection and HPV immune response before and after transplantation, and (ii) determine whether there is a link between HPV infection and immunosuppression.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Patients aged over 18 years
  • Patient waiting for first kidney transplant
  • Patients receiving a social security scheme
  • Postmenopausal women, surgically sterile or subjected to an effective method of contraception
  • Patient who signed the written consent

排除标准

  • Patients who have been transplanted
  • Pregnant women
  • Emergency situation Patients
  • Patients unable to give consent personally
  • Major protected Patients
  • Patients under judicial supervision

研究组 & 干预措施

kidney transplanted patient

Experimental

干预措施: Kidney transplanted patients (Other)

结局指标

主要结局

Prevalence of genital HPV infection before and after kidney transplantation in man and women

时间窗: 12 months

For woman, gynecologist perform cervical and anal samples with DNA pap cervical sampler. For men, dermatologist perform penis and anal samples with same device. The sample with perform when the patient are registered to waiting list for transplant and 3 months and one year after transplantation. The samples are genotyped using the kit INNO-LiPA HPV Genotyping Extra test (Innogenetics) which allows the detection of 28 HPV types.

次要结局

  • Anti-HPV 16 Antibody titer in blood before and after kidney transplantation in man and women(12 months)
  • Anti-HPV 18 Antibody titer in blood before and after kidney transplantation in man(12 months)

研究者

申办方类型
Other
责任方
Sponsor

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