Clinical trial NCT04837339: Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation
Official title: Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant Rejection
Lung Transplant Failure
Lung Transplant; Complications
Lung Transplant Failure and Rejection
Keywords: DATACOL
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 900
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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 outcomes:
measure: Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers).
timeFrame: 15 years
Secondary outcomes:
measure: Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression).
timeFrame: 15 years
measure: 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
timeFrame: 15 years
measure: Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection
timeFrame: 15 years
measure: Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection.
timeFrame: 15 years
measure: Assessing patient acceptability and well-being using invasive and non-invasive biomarkers
timeFrame: 15 years
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Roux
Study officials:
References: