Volatile Organic Compounds as Markers of Acute Rejection in Lung Transplant
NCT ID: NCT03172091
Last Updated: 2021-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2017-06-27
2021-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Acute rejection
Pulmonary transplant patients with acute rejection
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
Control group
Pulmonary transplant patients without acute rejection
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Jean-Louis Couderc, MD-PhD
Role: STUDY_CHAIR
Pneumologie Hopital Foch
Antoine Roux
Role: PRINCIPAL_INVESTIGATOR
Pneumologie Hopital Foch
Hélène Salvator, MD
Role: STUDY_CHAIR
Pneumologie Hopital Foch
Philippe Devillier, MD-PhD
Role: STUDY_CHAIR
UPRES EA 220 Hopital Foch
Locations
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Hopital Foch
Suresnes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2016-A00688-43
Identifier Type: OTHER
Identifier Source: secondary_id
2016/28
Identifier Type: -
Identifier Source: org_study_id
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