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

NCT04837339 | Recruiting

• 1 other identifier: 2019_0015
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

DATACOL

Outcome Measures

Primary Outcomes (1)

• Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers).

  Correlation between blood biomarkers (cell free DNA, Donor Specific Antibodies characterization) and graft rejection.

  15 years

Secondary Outcomes (5)

• Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression).

  15 years

• Stratify lung transplant recipients using non-invasive biomarkers and a gene expression profile for risk of allograft loss based on first year post-transplant data

  15 years

• Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection

  15 years

• Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection.

  15 years

• Assessing patient acceptability and well-being using invasive and non-invasive biomarkers

  15 years

Study Arms (1)

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

OTHER

There is no intervention to be administered.

Other: Collection of biological samples

Interventions

Collection of biological samples OTHER

Blood sample, biopsies sample, hair sample.

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Roux

Suresnes, France

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

Antoine ROUX, Dr

CONTACT

0146252635; a.roux@hopital-foch.com

Elisabeth HULLIER-AMMAR, Dr

CONTACT

0146251175; drci-promotion@hopital-foch.com

Study Design

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

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: April 8, 2021
• Study Start: March 17, 2022
• Primary Completion (Estimated): March 1, 2037
• Study Completion (Estimated): March 1, 2037
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

FR (1)