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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorHopital Foch

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Collection of biological samples

    Other intervention

    Blood sample, biopsies sample, hair sample.

Treatment groups

900 Participants
are divided into 1 treatment group
Group A: Patients with lung disease requiring transplantation or who have undergone lung transplantationOther 1 intervention

Trial outcomes

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.

Time frame
15 years

Secondary outcomes

1

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

Time frame
15 years
2

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.

Time frame
15 years
3

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

Time frame
15 years
4

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

Time frame
15 years

Other outcomes

Sponsors and contacts

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