Image

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

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

The diagnosis of AMR in lung transplant recipients is difficult and often comes too late, because of lack of standardized definition. The diagnosis is nowadays based on an expert multidisciplinary approach involving clinical, histopathological and immunological criteria.

Hypothesis: the presence of intragraft donor specific antibodies (gDSAs) could be used as a new diagnostic tool for AMR in lung transplant recipients Study Objectives: to evaluate, in lung transplant patients with circulating DSAs, the diagnostic value of gDSAs in AMR and to analyze its prognostic value on graft outcome.

Eligibility

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

Study details

Lung Transplant Recipient, Donor Specific Antibodies, Antibody Mediated Rejection

NCT03702257

University Hospital, Strasbourg, France

25 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.