Immunosuppression’s Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation

Overview

Cancer is a well known complication about long term transplantation. Cancer outcomes are due to the immunosuppressive treatment that prevents transplanted people from rejection. By lowering the effectiveness of the immune system, immune cells are no longer able to seek and destroy cancer cells. The goal here is to study immunes cells population of people that were transplanted 10 years ago and are now treated either by a corticosteroid – azathioprine association, or only by cyclosporine A.

Full Title of Study: “Immunosuppression’s Long Term Impact on Anti-tumoral Oversight in Kidney Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 15, 2018

Interventions

  • Biological: Immune cells population assesment
    • T lymphocytes population description through blood, urine and faeces samples

Arms, Groups and Cohorts

  • Other: ELITE

Clinical Trial Outcome Measures

Primary Measures

  • Immune cells study
    • Time Frame: 12 months
    • Study 2 types of T lymphocytes (by flow cytometry) that are suspected to be responsible of the graft non rejection and the cancer outcome, treated by corticosteroid – azathioprine association or cyclosporine A

Secondary Measures

  • bacteria study
    • Time Frame: 12 months
    • Study the modification of the intestinal bacteria population that might led to an “operational tolerance”, depending on the immunosuppressive treatment : the DNA will be extracted from the faeces and a typing will be carried out by Polymerase Chain Reaction
  • cancer incidence
    • Time Frame: 12 months
    • Assess cancer incidence, on a population of people with kidney transplantation (since 10 years) : observation of adverse events during visits

Participating in This Clinical Trial

Inclusion Criteria

  • Patients over 18 – Patients with kidney transplantation for 10 year – Patients with stable renal function (less than 20% creatinine variation during the last 12 months) – Patients treated either by a corticosteroid – azathioprine association or cyclosporine A – Patients giving his agreement – Patients legally free Exclusion Criteria:

  • Patients under 18 – Patients under legal protection – Pregnant women, or of age to get pregnant

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Poitiers University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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