Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06288646
Status:
TERMINATED
Last Update Posted:
2024-05-31
First Post:
2023-11-15
Brief Title:
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds VOCs in the Breath of Patients With Lung Cancer
Sponsor:
Breathe BioMedical Inc
Organization:
Breathe BioMedical Inc
Study Overview
Official Title:
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds VOCs in the Breath of Patients With Lung Cancer
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in sponsors business strategy disease focus changed to breast cancer
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare breath samples from patients with lung cancer those with stable lung nodules and individuals without lung cancer The main questions it aims to answer are whether breath patterns are different in these groups and to see if breath patterns change after treatment in patients with lung cancer
Participants will be asked to provide one breath sample and two if they get treated They will also be asked to fill out a questionnaire about their background and medical history
Participants will be asked to provide one breath sample and two if they get treated They will also be asked to fill out a questionnaire about their background and medical history
Detailed Description:
Globally lung cancer accounts for the most cancer deaths in both sexes combined It is believed to develop slowly through progressive accumulation of genetic mutations hence the disease allows time for diagnosis and curative surgical treatment Five year survival rates for non-small-cell lung carcinoma NSCLC can range from 57-61 when detected in the early stages of disease This is compared with a survival rate of approximately 6 once distant metastases are present However disease diagnosis typically occurs when it has progressed to an advanced stage when patients present with signs and symptoms Therefore technologies capable of asymptomatic disease detection will significantly impact lung cancer specific mortality Metabolomic profiling of cancer measures compounds produced as a result of cellular activity including volatile organic compounds VOCs in exhaled breath Infrared spectroscopy is a proven technique for breath analysis that can measure chemical concentrations in the parts per trillion range for certain VOCs When coupled with machine learning techniques this has the potential to be a novel approach for disease detection using exhaled breath
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