PApillomavirus in REnal Transplant Patient

Papillomavirus Infections Clinical Trial

— PATRE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845739
• Other study ID #: API/2009/09
• Status: Completed
• Phase: N/A
• First received: July 12, 2016
• Last updated: March 8, 2018
• Start date: January 1, 2011
• Est. completion date: November 10, 2017

Study information

• Verified date: March 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 10, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who have been transplanted

• Pregnant women

• Emergency situation Patients

• Patients unable to give consent personally

• Major protected Patients

• Patients under judicial supervision

Related Conditions & MeSH terms

• Papillomavirus Infections

Intervention

Other:
• Kidney transplanted patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of genital HPV infection before and after kidney transplantation in man and women	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.	12 months
Secondary	Anti-HPV 16 Antibody titer in blood before and after kidney transplantation in man and women	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.	12 months
Secondary	Anti-HPV 18 Antibody titer in blood before and after kidney transplantation in man	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.	12 months