NCT03227965

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2019

Completed
Last Updated

April 25, 2019

Status Verified

April 1, 2019

Enrollment Period

1.3 years

First QC Date

June 23, 2017

Last Update Submit

April 24, 2019

Conditions

Kidney Transplant; Complications

Keywords

cancer

Outcome Measures

Primary Outcomes (1)

  • Immune cells study

    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

    12 months

Secondary Outcomes (2)

  • bacteria study

    12 months

  • cancer incidence

    12 months

Study Arms (1)

ELITE

OTHER
Biological: Immune cells population assesment

Interventions

Immune cells population assesmentBIOLOGICAL

T lymphocytes population description through blood, urine and faeces samples

ELITE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Study Record Dates

First Submitted

June 23, 2017

First Posted

July 24, 2017

Study Start

January 13, 2017

Primary Completion

May 15, 2018

Study Completion

February 7, 2019

Last Updated

April 25, 2019

Record last verified: 2019-04

Locations

FR(1)