Overview

This trial is active, not recruiting.

Condition papillomavirus infections
Treatment kidney transplanted patients
Sponsor Centre Hospitalier Universitaire de Besancon
Start date January 2011
End date January 2018
Trial size 58 participants
Trial identifier NCT02845739, API/2009/09

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
kidney transplanted patients

Primary Outcomes

Measure
Prevalence of genital HPV infection before and after kidney transplantation in man and women
time frame: 12 months

Secondary Outcomes

Measure
Anti-HPV 16 Antibody titer in blood before and after kidney transplantation in man and women
time frame: 12 months
Anti-HPV 18 Antibody titer in blood before and after kidney transplantation in man
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Besancon.