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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Transplant Rejection; Lung Transplant Failure; Lung Transplant; Complications; Lung Transplant Failure and Rejection
• Intervention / Treatment: Other: Collection of biological samples

• Study Type: Interventional
• Enrollment (Anticipated): 900
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoine ROUX, Dr; Phone Number: +33 0146252635; Email: a.roux@hopital-foch.com
• Study Contact Backup: Name: Elisabeth HULLIER-AMMAR, Dr; Phone Number: 0146251175; Email: drci-promotion@hopital-foch.com

Study Locations

• France
  • Suresnes, France
    • Recruiting
    • Roux
    • Contact: Antoine Roux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with lung disease requiring transplantation or who have undergone lung transplantation; There is no intervention to be administered.	Other: Collection of biological samples; Blood sample, biopsies sample, hair sample.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression).	Correlation of biomarkers (graft) with the functionality of the allograft	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	Assessment of the risk of graft loss based on biomarker variations in repeated measurements.	15 years
Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection	Correlation between gene expression in lung transplants and response to treatment of rejection	15 years
Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection.	Costs incurred to define the risk of allograft rejection	15 years
Assessing patient acceptability and well-being using invasive and non-invasive biomarkers	Variation in patient well-being with the use of a non-invasive strategy to define the risk of allograft rejection	15 years

Collaborators and Investigators

• Sponsor: Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Anticipated): March 1, 2037
• Study Completion (Anticipated): March 1, 2037

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: DATACOL
• Other Study ID Numbers: 2019_0015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No