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Recruiting Not applicable

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

NCT04837339 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-03-17
Last updated
2022-08-03

Condition(s) studied

Lung Transplant RejectionLung Transplant FailureLung Transplant; ComplicationsLung Transplant Failure and Rejection

Investigational drug(s) / intervention(s)

Collection of biological samples

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

Study 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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers). — 15 years
    Correlation between blood biomarkers (cell free DNA, Donor Specific Antibodies characterization) and graft rejection.

Trial sites (1)

FacilityCityRegionStatus
Roux Suresnes France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04837339 on ClinicalTrials.gov ↗ ← All trials in France