DSA Intragraft in Lung Transplantation: Diagnostic and Prognostic Value in Antibody Mediated Reje… (NCT03702257) | Clinical Trial Compass
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DSA Intragraft in Lung Transplantation: Diagnostic and Prognostic Value in Antibody Mediated Rejection
France80 participantsStarted 2019-08-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.