Volatile Organic Compounds as Markers of Acute Rejection in Lung Transplant

Transplant; Complication, Rejection Clinical Trial

— VOC-TP  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03172091
• Other study ID #: 2016/28
• Secondary ID: 2016-A00688-43
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: October 2021

Study information

• Verified date: April 2021
• Source: Hopital Foch
• Contact: Hélène Salvator, MD
• Phone: +33(0)046252955
• Email: h.salvator[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transplant; Complication, Rejection

Intervention

Device:
• eNose (electronic nose)
Collection of exhaled breath for an immediate analysis by electronic nose
• Spectrometry
Collection of exhaled breath for an immediate analysis by mass spectrometry

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Acute rejection diagnosis	Comparison of discriminative capacity for diagnosis of acute rejection between the VOC analysis methods: electronic nose versus mass spectrometry.	1 day
Secondary	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