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

Not Applicable

Completed

• Conditions: Kidney Transplant; Complications
• Interventions: Biological: Immune cells population assesment

• Registration Number: NCT03227965
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-13
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-07-21
• Study First Posted: 2017-07-24
• Primary Completion: 2018-05-15
• Study Completion: 2019-02-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELITE	Immune cells population assesment	-

Primary Outcome Measures

Name	Time	Method
Immune cells study	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 Outcome Measures

Name	Time	Method
cancer incidence	12 months	Assess cancer incidence, on a population of people with kidney transplantation (since 10 years) : observation of adverse events during visits
bacteria study	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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Poitiers; 🇫🇷 Poitiers, France