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

Not Applicable

Recruiting

• Conditions: Donor Specific Antibodies; Antibody Mediated Rejection; Lung Transplant Recipient
• Interventions: Procedure: bronchoscopy.

• Registration Number: NCT03702257
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-08
• Study First Posted: 2018-10-11
• Study Start: 2019-08-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-11
• Last Update Posted: 2022-02-14
• Primary Completion: 2026-02-22
• Study Completion: 2026-02-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bronchial fibroscopy	bronchoscopy.	Bronchial fibroscopy with trans-bronchial biopsies

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Comparaison in gDSA+ vs gDSAs- patients	2 years	Incidence of graft loss

Trial Locations

Locations (5)

Hôpital Bichat; 🇫🇷 Paris, France

Hôpital Marie Lannelongue; 🇫🇷 Le Plessis Robinson, France

Les Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France

CHU Nord; 🇫🇷 Marseille, France

Hôpital Foch; 🇫🇷 Suresnes, France