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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchial fibroscopy | Other | Bronchial fibroscopy with trans-bronchial biopsies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bronchoscopy. | Procedure | gDSAs are studied on cryopreserved biopsies obtained during bronchoscopy. The technique is the one described by Visentin J. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of AMR | 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparaison in gDSA+ vs gDSAs- patients | Incidence of graft loss | 2 years |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine HIRSCHI | Contact | +33 3 69 55 11 78 | sandrine.hirschi@chru-strasbourg.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Marie Lannelongue | Not yet recruiting | Le Plessis-Robinson | 92350 | France |
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| CHU Nord | Recruiting | Marseille | 13915 | France |
|
| Hôpital Bichat | Not yet recruiting | Paris | 75018 | France |
|
| Les Hôpitaux Universitaires de Strasbourg | Recruiting | Strasbourg | 67091 | France |
|
| Hôpital Foch | Not yet recruiting | Suresnes | 92151 | France |
|
| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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