Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Collection of biological samples.
- Who it may be relevant to
- Registry conditions: Lung Transplant Rejection, Lung Transplant Failure, Lung Transplant; Complications, Lung Transplant Failure and Rejection. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Other Collection of biological samples
Blood sample, biopsies sample, hair sample.
Primary outcome measures
- Evaluate non-invasive markers of dysfunction to stratify the risk of rejection, present in the blood during the first year after transplantation (blood immunomarkers). [Time frame: 15 years]
Secondary outcome measures (5)
- Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression). [Time frame: 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 [Time frame: 15 years]
- Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection [Time frame: 15 years]
- Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection. [Time frame: 15 years]
- Assessing patient acceptability and well-being using invasive and non-invasive biomarkers [Time frame: 15 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Roux — Suresnes
Identifiers
NCT: NCT04837339 · 2019_0015