Immuno-humoral Rejection Markers in Pulmonary Transplant (RHUM-TP)

September 9, 2016 updated by: Hopital Foch

Humoral Rejection - Diagnostic Markers in Pulmonary Transplant.

Open multicentric prospective study performed on pulmonary transplanted patients to detect the values of different diagnostic markers for immuno- humoral reaction and their roles in the humoral rejection for those patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile de France
      • Suresnes, Ile de France, France, 92150
        • Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Both genders, more than 18 years of age.
  • Patients with or without Cystic fibrosis
  • Patients with no previous unilateral or bilateral pulmonary transplant or cardiopulmonary transplant
  • Patients with no current other disease can affect, in short term, the process or prognosis of the transplant
  • Patients had given his agreement to be enrolled in the study

Exclusion Criteria:

  • Patient less than 18 year-old
  • Patient had previous organ transplant
  • Pregnant and/or lactating women
  • Female subject in reproductive age does not use effective contraceptive methode
  • Alcoholisms or neuropsychosis, conditions that affect the good comprehension of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pulmonary transplant
Biological: Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of immune Markers of acute lung transplant rejection (Anti-HLA circulatory antibodies, neutrophils and C4d immune markers.
Time Frame: 12 months after pulmonary transplant
12 months after pulmonary transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

February 12, 2013

First Submitted That Met QC Criteria

February 12, 2013

First Posted (Estimate)

February 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 12, 2016

Last Update Submitted That Met QC Criteria

September 9, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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