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

Hopital Foch

Status: Enrolling

Conditions: Lung Transplant Rejection; Lung Transplant; Complications; Lung Transplant Failure; Lung Transplant Failure and Rejection

Treatments: Other: Collection of biological samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04837339

2019_0015

Details and patient eligibility

About

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.

Enrollment: 900 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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900 participants in 1 patient group

Patients with lung disease requiring transplantation or who have undergone lung transplantation

Other group

Description:

There is no intervention to be administered.

Treatment:

Other: Collection of biological samples