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NCT Number: NCT04837339

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

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.

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Key information

Conditions

Lung Transplant Rejection Behavior Lung Transplant Failure Lung Transplant Failure and Rejection Lung Transplant; Complications Rejection, Psychology Social Behavior

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roux

Suresnes, France

Location status: Recruiting

Location contact

Antoine Roux

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Collection of biological samples

Other

Blood sample, biopsies sample, hair sample.

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).

    Time frame: 15 years

    Correlation between blood biomarkers (cell free DNA, Donor Specific Antibodies characterization) and graft rejection.

Secondary outcomes

  1. Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression).

    Time frame: 15 years

    Correlation of biomarkers (graft) with the functionality of the allograft

  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

    Time frame: 15 years

    Assessment of the risk of graft loss based on biomarker variations in repeated measurements.

  3. Identify biomarkers and gene sets associated with response to immunosuppressive treatments of rejection

    Time frame: 15 years

    Correlation between gene expression in lung transplants and response to treatment of rejection

  4. Evaluate the costs associated with the use of invasive and non-invasive strategies to define the risk of allograft rejection.

    Time frame: 15 years

    Costs incurred to define the risk of allograft rejection

  5. Assessing patient acceptability and well-being using invasive and non-invasive biomarkers

    Time frame: 15 years

    Variation in patient well-being with the use of a non-invasive strategy to define the risk of allograft rejection

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine ROUX, Dr

CONTACT

[email protected]

0146252635 ext. +33

Elisabeth HULLIER-AMMAR, Dr

CONTACT

[email protected]

0146251175

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: DATACOL

Important dates

Study start
2022
Primary completion
2037
Study completion
2037
First posted
Apr 8, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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