Immuno-humoral Rejection Markers in Pulmonary Transplant

NCT ID: NCT01791166

Last Updated: 2016-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pulmonary transplant

Group Type EXPERIMENTAL

Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests

Intervention Type BIOLOGICAL

Interventions

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Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital FOCH

Suresnes, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2010/49

Identifier Type: -

Identifier Source: org_study_id

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