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

NCT03702257 | Recruiting

• 1 other identifier: 7039
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

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.

Conditions

Lung Transplant Recipient; Donor Specific Antibodies; Antibody Mediated Rejection

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Comparaison in gDSA+ vs gDSAs- patients

  2 years

Study Arms (1)

Bronchial fibroscopy

OTHER

Bronchial fibroscopy with trans-bronchial biopsies

Procedure: bronchoscopy.

Interventions

bronchoscopy. PROCEDURE

gDSAs are studied on cryopreserved biopsies obtained during bronchoscopy. The technique is the one described by Visentin J.

Bronchial fibroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 18 years
• Transplanted pulmonary or cardiopulmonary patient
• 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

You may not qualify if:

• Patient whose anti-HLA antibodies are not directed against the graft (no DSA)
• Contraindication to performing a bronchial fibroscopy with transbronchial biopsies
• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (5)

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

NOT YET RECRUITING

CHU Nord

Marseille, 13915, France

RECRUITING

Hôpital Bichat

Paris, 75018, France

NOT YET RECRUITING

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

Hôpital Foch

Suresnes, 92151, France

NOT YET RECRUITING

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Central Study Contacts

Sandrine HIRSCHI

CONTACT

+33 3 69 55 11 78; sandrine.hirschi@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 11, 2018
• Study Start: August 23, 2019
• Primary Completion: February 22, 2026
• Study Completion: February 22, 2026
• Last Updated: February 14, 2022

Record last verified: 2022-02

Locations

FR (5)