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OpenTrials
Completed

NCT Number: NCT03227965

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

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.

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Key information

Conditions

Kidney Transplant; Complications Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immune cells population assesment

Biological

T lymphocytes population description through blood, urine and faeces samples

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jul 24, 2017
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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