DSA Intragraft in Lung Transplantation: Diagnostic and Prognostic Value in Antibody Mediated Rejection

Launched by UNIVERSITY HOSPITAL, STRASBOURG, FRANCE · Oct 8, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new way to diagnose a condition called antibody-mediated rejection (AMR) in people who have received a lung transplant. AMR can be hard to identify and often goes undetected until it is too late. Researchers believe that checking for specific antibodies in the lung tissue (called intragraft donor specific antibodies or gDSAs) could help diagnose AMR earlier and improve patient outcomes. The goal is to see if finding these antibodies can help doctors understand how well the lung transplant is working and guide better treatment options.

To participate in this study, you must be at least 18 years old and have received a lung transplant. You also need to have developed certain antibodies against the transplant within the last month. If you join the study, you will undergo tests to check for these antibodies and possibly have a procedure to take a small sample of lung tissue. This research could help improve care for future lung transplant patients, so your involvement may contribute to important advancements in this area.

Gender

ALL

Eligibility 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