Volatile Organic Compounds as Markers of Acute Rejection in Lung Transplant — VOC-TP  

Transplant; Complication, Rejection Clinical Trial

Official title: Analysis of Volatile Organic Compounds in the Exhaled Air Breath of in Bilateral Lung Transplant Recipients Bi-pulmonary Transplant Patients: Search for Acute Rejection Markers

Status Recruiting

Clinical Trial Summary

The aim of research is to identify markers of acute rejection by VOC analysis in exhaled breath of bilateral-lung transplanted patients. 120 bi-lung transplanted patients will be divided into two groups : patients with acute rejection diagnosed on transbronchial biopsies and patients with no acute rejection. Exhaled breath will be collected for VOC analysis woth electronic nose and mass spectrometry. VOC profiles will be compared between the two groups of patients.

Clinical Trial Description

Prospective single-center study. A single visit, no follow-up. The visit will take place before or within five days from date of transbronchial biopsies (BTB). It will include a noninvasive collection of exhaled breath for VOC analysis. VOC analysis will be conducted using two types of devices: "electronic nose" and mass spectrometry.

200 bi-lung transplanted patients will be enrolled and divided into two groups.

• Group A, Acute rejection: 100 patients. Diagnosis of acute rejection retained on transbronchial biopsies or functional anomalies with the necessity of modifying the immunosuppressive regimen.

• Group B, control: 100 patients. Patients without respiratory functional abnormality and normal transbronchial biopsy.

VOC, detected by electronic nose and identified by mass spectrometry, will be compared between patients with a confirmed diagnosis of acute rejection (group A) and patients without rejection (control group B)

The duration of participation of each patient is 1 day. The duration of the inclusion period is estimated at 54 months from the first inclusion. The expected total duration of the research is 54 months ;

Related Conditions & MeSH terms

• Transplant; Complication, Rejection

• NCT number: NCT03172091
• Study type: Interventional
• Source: Hopital Foch
• Contact: Hélène Salvator, MD
• Phone: +33(0)046252955
• Email: h.salvator@hopital-foch.com
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2017
• Completion date: October 2021