Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation

NCT ID: NCT04837339

Last Updated: 2022-08-03

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

RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-17

Study Completion Date

2037-03-31

Brief Summary

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Transplant results vary considerably from one organ to another. Lung transplantation has poorer long-term outcomes than other solid organ transplants, with a current median post-transplant survival of 6.0 years. Allograft rejection remains the leading cause of morbidity and mortality in all organ groups and is the leading cause of death, accounting for more than 40% of deaths beyond the first year after lung transplantation.

Each dysfunctions impacts the fate of the graft and therefore the survival of the recipient. Their early and precise diagnosis is therefore a major issue. The identification of the pathophysiological mechanisms underlying these different subtypes of dysfunction (transcriptomics, polymorphism of target genes of the immune system or tissue repair, cell phenotyping) is an essential step. It can only be done on the basis of a collection of samples linked to a clinical database allowing to contextualize each sample.

Detailed Description

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Conditions

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Lung Transplant Rejection Lung Transplant Failure Lung Transplant; Complications Lung Transplant Failure and Rejection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with lung disease requiring transplantation or who have undergone lung transplantation

There is no intervention to be administered.

Group Type OTHER

Collection of biological samples

Intervention Type OTHER

Blood sample, biopsies sample, hair sample.

Interventions

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Collection of biological samples

Blood sample, biopsies sample, hair sample.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men or women over 15 years of age
* Suffering from a lung condition requiring a transplant planned at Foch Hospital or being followed up at Foch Hospital following a lung transplant
* Have signed the informed consent form and for patients aged 15 to 18 years that the person(s) exercising parental authority has/have signed the informed consent.
* Be affiliated with a Health Insurance plan.

Exclusion Criteria

* Pregnant, parturient and/or lactating woman
* Hemoglobin level less than or equal to 8g/dl
* Persons of full age who are subject to a legal protection measure or who are unable to express their consent
* Persons under the protection of justice
* Not being able to follow the study requirements for geographical, social or psychological reasons
* Patient refusal.
Minimum Eligible Age

15 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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Roux

Suresnes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Antoine ROUX, Dr

Role: CONTACT

0146252635 ext. +33

Elisabeth HULLIER-AMMAR, Dr

Role: CONTACT

0146251175

Facility Contacts

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Antoine Roux

Role: primary

Other Identifiers

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2019_0015

Identifier Type: -

Identifier Source: org_study_id

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