Using donor specific antibodies to improve diagnosis of rejection in lung transplant patients
Intérêt Diagnostique et Pronostique de la présence d'Anticorps spécifiques du Donneur Intra-greffon Dans le Rejet Humoral en Transplantation Pulmonaire
This study is testing if checking for certain antibodies in lung transplant patients can help doctors better diagnose rejection and improve patient outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Drugs / interventions | Rituximab |
| Locations | 5 sites (Le Plessis Robinson and 4 other locations) |
| Trial ID | NCT03702257 on ClinicalTrials.gov |
What this trial studies
This study evaluates the diagnostic and prognostic value of intragraft donor specific antibodies (gDSAs) in lung transplant recipients who have developed circulating donor specific antibodies (DSAs). The research aims to determine if the presence of gDSAs can serve as a reliable diagnostic tool for antibody mediated rejection (AMR) and to analyze its impact on graft outcomes. The approach involves performing bronchoscopy to assess the presence of gDSAs in patients who meet specific eligibility criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are lung transplant recipients over 18 years old who have developed circulating donor specific antibodies at a specified threshold.
Not a fit: Patients who do not have donor specific antibodies or have contraindications to bronchoscopy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of antibody mediated rejection in lung transplant patients, potentially improving graft survival rates.
How similar studies have performed: While the approach of using gDSAs for diagnosis is innovative, similar studies have not been widely reported, indicating this may be a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Patient older than 18 years * Transplanted pulmonary or cardiopulmonary patient * And developing circulating anti-HLA antibodies directed against the graft or "DSA" at a threshold \> 1000 of MFI in the 30 days preceding the inclusion visit * Affiliation to the French social security * Patient able to understand the objectives and risks related to research and to give informed, dated and signed consent Exclusion criteria: * Patient whose anti-HLA antibodies are not directed against the graft (no DSA) * Contraindication to performing a bronchial fibroscopy with transbronchial biopsies * Treatment with intravenous immunoglobulin (less than 1 month before inclusion) or Rituximab (less than 6 months before inclusion) * Plasma exchanges (less than 3 months before inclusion) * Risk of bleeding predictable (crushing disorder, impossibility of stopping the offending treatments) * Impossibility of giving the subject informed information * Subject under the protection of justice Subject under guardianship or curatorship * Pregnancy * Breastfeeding
Where this trial is running
Le Plessis Robinson and 4 other locations
- Hôpital Marie Lannelongue — Le Plessis Robinson, France (Not_yet_recruiting)
- CHU Nord — Marseille, France (Recruiting)
- Hôpital Bichat — Paris, France (Not_yet_recruiting)
- Les Hôpitaux Universitaires de Strasbourg — Strasbourg, France (Recruiting)
- Hôpital Foch — Suresnes, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Sandrine HIRSCHI
- Email: sandrine.hirschi@chru-strasbourg.fr
- Phone: +33 3 69 55 11 78
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.