PApillomavirus in REnal Transplant Patient (PATRE)
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|ClinicalTrials.gov Identifier: NCT02845739|
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : March 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Papillomavirus Infections||Other: Kidney transplanted patients||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Study of the Distribution of Genotypes of HPV at the Ano-genital Area and Peripheral Humoral Immune Response Before and After Kidney Transplantation|
|Actual Study Start Date :||January 1, 2011|
|Actual Primary Completion Date :||November 10, 2017|
|Actual Study Completion Date :||November 10, 2017|
|Experimental: kidney transplanted patient||
Other: Kidney transplanted patients
- Prevalence of genital HPV infection before and after kidney transplantation in man and women [ Time Frame: 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.
- Anti-HPV 16 Antibody titer in blood before and after kidney transplantation in man and women [ Time Frame: 12 months ]Blood sample are taken in patient before, the day of transplantation and before. Titer (UI) of anti-HPV 16 antibody a serology is performed by ELISA.
- Anti-HPV 18 Antibody titer in blood before and after kidney transplantation in man [ Time Frame: 12 months ]Blood sample are taken in patient before, the day of transplantation and before. Titer (UI) of anti-HPV 18 antibody a serology is performed by ELISA.