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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Transplant; Complication, Rejection
• Intervention / Treatment: Device: eNose (electronic nose); Device: Spectrometry

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hélène Salvator, MD; Phone Number: +33(0)046252955; Email: h.salvator@hopital-foch.com

Study Locations

• France
  • Suresnes, France, 92150
    • Recruiting
    • Hôpital FOCH
    • Contact: Antoine Roux; Phone Number: +33(0)146253731; Email: a.roux@hopital-foch.org
    • Principal Investigator: Antoine Roux, MD
    • Sub-Investigator: Helene Salvator, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Bi-pulmonary transplant patient
• Acute rejection group: Patients with transbronchial biopsies performed as part of their usual follow-up or for functional abnormality ; Diagnosis of acute rejection retained on the following arguments: histological lesions of cellular rejection or histological lesions of humoral rejection or normal histology but diagnosis of "functional rejection" retained and immunosuppressive treatment indicated
• Control group: Patients benefiting from systematically programmed transbronchial biopsies as part of post-transplant follow-up with normal histology and absence of functional respiratory abnormality

Exclusion Criteria:

• Patient unable to realize a vital capacity measure
• Neoplasia currently treated
• Unresolved acute bronchial complication (stenosis or dehiscence)
• Immunosuppressive treatment of acute rejection already begun
• Patient who has already participated in the protocol and already included in one of the two study groups

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acute rejection; Pulmonary transplant patients with acute rejection	Device: eNose (electronic nose); Collection of exhaled breath for an immediate analysis by electronic nose; Device: Spectrometry; Collection of exhaled breath for an immediate analysis by mass spectrometry
Other: Control group; Pulmonary transplant patients without acute rejection	Device: eNose (electronic nose); Collection of exhaled breath for an immediate analysis by electronic nose; Device: Spectrometry; Collection of exhaled breath for an immediate analysis by mass spectrometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volatile Organic Compounds by electronic nose (eNose)	Comparison of Volatile Organic Compounds profile detected by electronic nose between lung transplant patients patients with a confirmed diagnosis of acute rejection and patients without rejection	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volatile Organic Compounds profile	Comparison of Volatile Organic Compounds profile identified by mass spectrometry electronic nose between lung transplant patients with a confirmed diagnosis of acute rejection and patients without rejection	1 day
Acute rejection diagnosis	Comparison of discriminative capacity for diagnosis of acute rejection between the VOC analysis methods: electronic nose versus mass spectrometry.	1 day
Volatile Organic Compounds by spectrometry	Determining distinct exhaled VOC profiles associated with each type of acute rejection: cellular rejection, humoral rejection or functional rejection	1 day

Collaborators and Investigators

• Sponsor: Hopital Foch
• Investigators: Study Chair: Jean-Louis Couderc, MD-PhD, Pneumologie Hôpital Foch; Principal Investigator: Antoine Roux, Pneumologie Hôpital Foch; Study Chair: Hélène Salvator, MD, Pneumologie Hôpital Foch; Study Chair: Philippe Devillier, MD-PhD, UPRES EA 220 Hopital Foch

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 22, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Lung transplant; Volatile Organic Compounds; Acute resection
• Other Study ID Numbers: 2016/28; 2016-A00688-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No