PApillomavirus in REnal Transplant Patient

NCT02845739 | Completed

• 1 other identifier: API/2009/09
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Papillomavirus Infections

Keywords

kidney transplantation; human papillomavirus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anti-HPV 16 Antibody titer in blood before and after kidney transplantation in man and women

  12 months

• Anti-HPV 18 Antibody titer in blood before and after kidney transplantation in man

  12 months

Study Arms (1)

kidney transplanted patient

EXPERIMENTAL

Other: Kidney transplanted patients

Interventions

Kidney transplanted patients OTHER

kidney transplanted patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who have been transplanted
• Pregnant women
• Emergency situation Patients
• Patients unable to give consent personally
• Major protected Patients
• Patients under judicial supervision

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 27, 2016
• Study Start: January 1, 2011
• Primary Completion: November 10, 2017
• Study Completion: November 10, 2017
• Last Updated: March 9, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share