NCT03474536

Brief Summary

The aim is to compare the quantitative parameters of de novo anti-HLA DQ Donor Specific Antibodies (DSA), determined at the time of their discovery by surface plasmon resonance (SPR), between recipients that developed a Chronic Lung Allograft Dysfunction (CLAD) for the 2 years following DSA apparition and those who did not. If concentration, kinetics and/or affinity parameters of anti-DQ DSA are associated with CLAD development, new, non-invasive prognostic biomarkers of humoral rejection in lung transplantation will be discovered .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

March 14, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2025

Completed
Last Updated

July 4, 2025

Status Verified

July 1, 2025

Enrollment Period

7.1 years

First QC Date

March 5, 2018

Last Update Submit

July 1, 2025

Conditions

Lung TransplantationAntibody Mediated RejectionChronic Lung Allograft Dysfunction

Keywords

Lung transplantationHLA antibodiesconcentrationaffinitysurface plasmon resonance

Outcome Measures

Primary Outcomes (1)

  • CLAD development

    CLAD development within the 2 years following DSA apparition

    2 years

Secondary Outcomes (3)

  • raft loss up to 5 years following DSA apparition

    6 months, 1 year, 2 years, 5 years

  • CLAD development

    6 months

  • CLAD development

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

122 patients with lung transplantation at University Hospital of Bordeaux and 4 departments of lung transplantation from Paris (Marie Lannelongue, Foch, Bichat and HEGP hospitals

You may qualify if:

  • Age 18 years and older
  • Patient transplanted between 01/01/2001 and 31/07/2016
  • Patient with immunodominant anti-HLA DQ de novo DSA developed before 08/2016
  • Patient for who sufficient remaining serum quantity is available in usual care biobank
  • non-opposition of the patient

You may not qualify if:

  • preformed DSA at the transplantation;
  • Non immunodominant DQ DSA ;
  • Insufficient serum quantity in usual care biobank
  • Inability to determine the date of DSA apparition at around one year
  • opposition of the patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Bordeaux

Bordeaux, France

Location

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

AP-HP Hôpital Bichat

Paris, 75877, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 22, 2018

Study Start

March 14, 2018

Primary Completion

April 8, 2025

Study Completion

April 8, 2025

Last Updated

July 4, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)