NCT03172091

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

June 27, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

4.3 years

First QC Date

May 29, 2017

Last Update Submit

April 22, 2021

Conditions

Transplant; Complication, Rejection

Keywords

Lung transplantAcute resectionVolatile Organic Compounds

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Volatile Organic Compounds profile

    1 day

  • Acute rejection diagnosis

    1 day

  • Volatile Organic Compounds by spectrometry

    1 day

Study Arms (2)

Acute rejection

EXPERIMENTAL

Pulmonary transplant patients with acute rejection

Device: eNose (electronic nose)Device: Spectrometry

Control group

OTHER

Pulmonary transplant patients without acute rejection

Device: eNose (electronic nose)Device: Spectrometry

Interventions

eNose (electronic nose)DEVICE

Collection of exhaled breath for an immediate analysis by electronic nose

Acute rejectionControl group
SpectrometryDEVICE

Collection of exhaled breath for an immediate analysis by mass spectrometry

Acute rejectionControl group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Electronic NoseSpectrum Analysis

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesElectrical Equipment and SuppliesChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Jean-Louis Couderc, MD-PhD

    Pneumologie Hopital Foch

    STUDY CHAIR

  • Antoine Roux

    Pneumologie Hopital Foch

    PRINCIPAL INVESTIGATOR

  • Hélène Salvator, MD

    Pneumologie Hopital Foch

    STUDY CHAIR

  • Philippe Devillier, MD-PhD

    UPRES EA 220 Hopital Foch

    STUDY CHAIR

Central Study Contacts

Hélène Salvator, MD

CONTACT

+33(0)046252955h.salvator@hopital-foch.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 1, 2017

Study Start

June 27, 2017

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)