search
Back to results

PApillomavirus in REnal Transplant Patient (PATRE)

Primary Purpose

Papillomavirus Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kidney transplanted patients
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Papillomavirus Infections focused on measuring kidney transplantation, human papillomavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    kidney transplanted patient

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    July 12, 2016
    Last Updated
    March 8, 2018
    Sponsor
    Centre Hospitalier Universitaire de Besancon
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02845739
    Brief Title
    PApillomavirus in REnal Transplant Patient
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2011 (Actual)
    Primary Completion Date
    November 10, 2017 (Actual)
    Study Completion Date
    November 10, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Papillomavirus Infections
    Keywords
    kidney transplantation, human papillomavirus

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    kidney transplanted patient
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    Kidney transplanted patients
    Primary Outcome Measure Information:
    Title
    Prevalence of genital HPV infection before and after kidney transplantation in man and women
    Description
    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.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Anti-HPV 16 Antibody titer in blood before and after kidney transplantation in man and women
    Description
    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.
    Time Frame
    12 months
    Title
    Anti-HPV 18 Antibody titer in blood before and after kidney transplantation in man
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    PApillomavirus in REnal Transplant Patient

    We'll reach out to this number within 24 hrs