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

Lung Transplant; Complications Clinical Trial

— DATACOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837339
• Other study ID #: 2019_0015
• Status: Recruiting
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: March 2037

Study information

• Verified date: August 2022
• Source: Hopital Foch
• Contact: Antoine ROUX, Dr
• Phone: 0146252635
• Email: a.roux[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: March 2037
• Est. primary completion date: March 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Collection of biological samples
Blood sample, biopsies sample, hair sample.

Locations

Country	Name	City	State
France	Roux	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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