Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06135220
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-11-13
Brief Title:
Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath
Sponsor:
Aalborg University Hospital
Organization:
Aalborg University Hospital
Study Overview
Official Title:
Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NILEX
Brief Summary:
In this study a new non-invasive method for diagnosis of pulmonary embolism PE will be tested
In pre-clinical studies the investigators have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath and several of these were also found in a first in-human clinical study what the investigators performed in 2019-2020 DOI 1010881752-7163ad0aaa These biomarkers need consolidation in a clinical setting using an updated collection device and proteomic analysis platform before development of a prototype and further test of this new diagnostic method
In pre-clinical studies the investigators have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath and several of these were also found in a first in-human clinical study what the investigators performed in 2019-2020 DOI 1010881752-7163ad0aaa These biomarkers need consolidation in a clinical setting using an updated collection device and proteomic analysis platform before development of a prototype and further test of this new diagnostic method
Detailed Description:
The study will compare the protein profiles of exhaled breath from patients admitted to the Emergency Care Center with suspected pulmonary embolism and controls with same age within a range of 10 years and gender The main-outcome ie means of the relative amounts of specific proteins in the exhaled breath samples will be compared by unpaired t-tests after assessment of normality and standard deviations within the two groups PE patients and controls Furthermore sensitivity and specificity will be calculated for relevant proteins The results from analysis of exhaled breath samples from the patients and controls will be compared with results from the porcine model and the first clinical study to confirm and reduce the number of putative biomarkers for PE
Blood samples ie excess plasma from routine blood samples drawn as a part of routine diagnostic work-up from the study participants will be stored for standardization of the putative markers and verification and supplementing analysis of the exhaled breath markers In order to qualify the most suitable markers and substrates for standardization the analysis of the exhaled breath samples must be completed before the blood samples can be analyzed Only biochemical no genetic analysis will be conducted
Blood samples ie excess plasma from routine blood samples drawn as a part of routine diagnostic work-up from the study participants will be stored for standardization of the putative markers and verification and supplementing analysis of the exhaled breath markers In order to qualify the most suitable markers and substrates for standardization the analysis of the exhaled breath samples must be completed before the blood samples can be analyzed Only biochemical no genetic analysis will be conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 108272 | OTHER | Den Videnskabsetiske Komite for Region Nordjylland | None |