Transplant; Complication, RejectionVOC-TPNCT03172091
Volatile Organic Compounds as Markers of Acute Rejection in Lung Transplant
A study testing eNose (electronic nose) and Spectrometry in people with Transplant; Complication, Rejection, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant; Complication, Rejection
- What is being tested?
- eNose (electronic nose) and Spectrometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2017to Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Foch
Suresnes, 92150
Antoine Roux, +33(0)146253731, a.roux@hopital-foch.org
Antoine Roux, MD
About this study
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
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.
Read the 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
- Conditions
- Transplant; Complication, Rejection
- Being tested
- eNose (electronic nose), Spectrometry
- Keywords
- Lung transplant, Acute resection, Volatile Organic Compounds
- Medical subject headings
- Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eNose (electronic nose)Device
Collection of exhaled breath for an immediate analysis by electronic nose
SpectrometryDevice
Collection of exhaled breath for an immediate analysis by mass spectrometry
| Study group | Role | What they receive |
|---|---|---|
| Acute rejection | Experimental | Pulmonary transplant patients with acute rejection Receives: Device: eNose (electronic nose); Device: Spectrometry |
| Control group | Other | Pulmonary transplant patients without acute rejection Receives: Device: eNose (electronic nose); Device: Spectrometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
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
Measured: 1 day
Acute rejection diagnosis
Comparison of discriminative capacity for diagnosis of acute rejection between the VOC analysis methods: electronic nose versus mass spectrometry.
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start27 Jun 2017
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant; Complication, RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Couderc, MD-PhD, Study chair, Pneumologie Hopital FochAntoine Roux, Principal investigator, Pneumologie Hopital FochHélène Salvator, MD, Study chair, Pneumologie Hopital FochPhilippe Devillier, MD-PhD, Study chair, UPRES EA 220 Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172091
- Sponsor's protocol ID
- 2016/28
- Other IDs
- 2016-A00688-43
- Acronym
- VOC-TP
- Status last verified
- Apr 2021
- First submitted
- 29 May 2017
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03172091
- Acronym / sponsor ID
- VOC-TP / 2016/28
- Conditions
- Transplant; Complication, Rejection
- Keywords
- Lung transplant, Acute resection, Volatile Organic Compounds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute rejection | Experimental | Device: eNose (electronic nose), Device: SpectrometryPulmonary transplant patients with acute rejection |
| Control group | Other | Device: eNose (electronic nose), Device: SpectrometryPulmonary transplant patients without acute rejection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eNose (electronic nose)Collection of exhaled breath for an immediate analysis by electronic nose | Device | Acute rejection, Control group |
| SpectrometryCollection of exhaled breath for an immediate analysis by mass spectrometry | Device | Acute rejection, Control group |
Primary outcome
Volatile Organic Compounds by electronic nose (eNose)
Time frame: 1 day
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
3 secondary outcomes
Volatile Organic Compounds profile
Time frame: 1 day
Acute rejection diagnosis
Time frame: 1 day
Volatile Organic Compounds by spectrometry
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Couderc, MD-PhD study chair
Pneumologie Hopital Foch
Antoine Roux principal investigator
Pneumologie Hopital Foch
Hélène Salvator, MD study chair
Pneumologie Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eNose (electronic nose) and Spectrometry in people with Transplant; Complication, Rejection, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hélène Salvator, MD (+33(0)046252955, h.salvator@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volatile Organic Compounds by electronic nose (eNose) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.