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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A00688-43 | Other Identifier | ANSM |
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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.
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute rejection | Experimental | Pulmonary transplant patients with acute rejection |
|
| Control group | Other | Pulmonary transplant patients without acute rejection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eNose (electronic nose) | Device | Collection of exhaled breath for an immediate analysis by electronic nose |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hélène Salvator, MD | Contact | +33(0)046252955 | h.salvator@hopital-foch.com |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Louis Couderc, MD-PhD | Pneumologie Hopital Foch | Study Chair |
| Antoine Roux | Pneumologie Hopital Foch | Principal Investigator |
| Hélène Salvator, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Foch | Recruiting | Suresnes | 92150 | France |
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| ID | Term |
|---|---|
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D062609 | Electronic Nose |
| D013057 | Spectrum Analysis |
| ID | Term |
|---|---|
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
| D055615 | Electrical Equipment and Supplies |
| D002623 | Chemistry Techniques, Analytical |
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| Spectrometry | Device | Collection of exhaled breath for an immediate analysis by mass spectrometry |
|
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 |
| Pneumologie Hopital Foch |
| Study Chair |
| Philippe Devillier, MD-PhD | UPRES EA 220 Hopital Foch | Study Chair |
| D008919 | Investigative Techniques |