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

Sponsor
Hopital Foch (Other)
Overall Status
Recruiting
CT.gov ID
NCT04837339
Collaborator
(none)
900
1
1
179.5
5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Collection of biological samples
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
900 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Diagnostic and Prognostic Biomarkers of Transplant Dysfunction in the Context of Lung Transplantation
Actual Study Start Date :
Mar 17, 2022
Anticipated Primary Completion Date :
Mar 1, 2037
Anticipated Study Completion Date :
Mar 1, 2037

Arms and Interventions

Arm Intervention/Treatment
Other: Patients with lung disease requiring transplantation or who have undergone lung transplantation

There is no intervention to be administered.

Other: Collection of biological samples
Blood sample, biopsies sample, hair sample.

Outcome Measures

Primary Outcome Measures

  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). [15 years]

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

Secondary Outcome Measures

  1. Evaluate relevant gene sets associated with high or low risk profiles of acute dysfunction and rejection (intragraft expression). [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 [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 [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. [15 years]

    Costs incurred to define the risk of allograft rejection

  5. Assessing patient acceptability and well-being using invasive and non-invasive biomarkers [15 years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Roux Suresnes France

Sponsors and Collaborators

  • Hopital Foch

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT04837339
Other Study ID Numbers:
  • 2019_0015
First Posted:
Apr 8, 2021
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hopital Foch

Study Results

No Results Posted as of Aug 3, 2022