Analyzing HLA-DQ Antibodies in Lung Transplant Patients
Clinical Impact of Concentration and Affinity of HLA-DQ Antibodies in Lung Transplantation - AFFIHLA-P
This study is testing if measuring certain antibodies in lung transplant patients can help predict who might develop long-term lung problems after their transplant.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 93 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 5 sites (Bordeaux and 4 other locations) |
| Trial ID | NCT03474536 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the quantitative parameters of de novo anti-HLA DQ Donor Specific Antibodies (DSA) in lung transplant recipients who developed Chronic Lung Allograft Dysfunction (CLAD) versus those who did not. Using surface plasmon resonance (SPR), the study will assess the concentration, kinetics, and affinity of these antibodies at the time of their discovery. The goal is to identify potential non-invasive prognostic biomarkers for humoral rejection in lung transplantation by evaluating how these parameters correlate with CLAD development over a two-year period.
Who should consider this trial
Good fit: Ideal candidates are lung transplant recipients aged 18 and older who developed immunodominant anti-HLA DQ de novo DSA between 2001 and 2016.
Not a fit: Patients with preformed DSA or insufficient serum quantity in the biobank will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of new biomarkers that help predict and manage CLAD in lung transplant patients.
How similar studies have performed: While the approach of using SPR for antibody analysis is innovative, similar studies have not been widely reported, making this a potentially novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Bordeaux and 4 other locations
- CHU Bordeaux — Bordeaux, France (Recruiting)
- Hôpital Marie Lannelongue — Le Plessis-Robinson, France (Recruiting)
- Hôpital Européen Georges Pompidou — Paris, France (Completed)
- AP-HP Hôpital Bichat — Paris, France (Recruiting)
- Hôpital Foch — Suresnes, France (Recruiting)
Study contacts
- Study coordinator: Jonathan Visentin, MD, Ph.D
- Email: jonathan.visentin@chu-bordeaux.fr
- Phone: +33557 82 08 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.