PApillomavirus in REnal Transplant Patient

NCT ID: NCT02845739

Last Updated: 2018-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2017-11-10

Brief 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.

Detailed 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.

Conditions

Papillomavirus Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

kidney transplanted patient

Group Type: EXPERIMENTAL

Kidney transplanted patients

Intervention Type: OTHER

Interventions

Kidney transplanted patients

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

API/2009/09

Identifier Type: -

Identifier Source: org_study_id