Antibody Mediated Rejection, Donor Specific Antibodies, Lung Transplant Recipient
Conditions
Brief 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.
Interventions
PROCEDUREbronchoscopy.
gDSAs are studied on cryopreserved biopsies obtained during bronchoscopy. The technique is the one described by Visentin J.
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnosis of AMR | 2 years | Sensitivity and specificity of the presence of gDSA for the diagnosis of AMR in lung transplant recipients with circulating DSA, as established by an expert pathologist panel and in accordance with recent international recommendations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparaison in gDSA+ vs gDSAs- patients | 2 years | Incidence of graft loss |
Countries
France
Contacts
Primary ContactSandrine HIRSCHI
Outcome results
None listed