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
About this trial
This is an interventional basic science trial for Papillomavirus Infections focused on measuring kidney transplantation, human papillomavirus
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
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
NCT ID
NCT02845739
First Posted
July 12, 2016
Last Updated
March 8, 2018
Sponsor
Centre Hospitalier Universitaire de Besancon
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