Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512350
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Identifying Patterns in the Breath of Individuals With Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Using Infrared Spectroscopy to Analyze Volatile Organic Compounds in the Breath of Patients With Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational collection protocol is to develop a machine learning model capable of differentiating between the breath profiles of individuals with breast cancer and those without breast cancer
The purpose of this collection protocol is
To further develop Breathe BioMedicals technology and machine learning algorithms to detect breast cancer in women with dense breast tissue
To identify patterns of compounds that are either over- or under-represented in the breath of women with breast cancer compared to the breath of women without breast cancer
To assess performance characteristics eg sensitivity specificity false negative rate and false positive rate including subgroup analyses
To pool and analyze de-identified data from this previous and future breath analysis studies
Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection
Women with mammogram-confirmed dense breast tissues undergoing standard-of-care breast cancer screening will be invited to participate Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators Breath samples will be collected prior to standard of care biopsy or MRI and patients will be stratified into the case or control group based on their test results
The purpose of this collection protocol is
To further develop Breathe BioMedicals technology and machine learning algorithms to detect breast cancer in women with dense breast tissue
To identify patterns of compounds that are either over- or under-represented in the breath of women with breast cancer compared to the breath of women without breast cancer
To assess performance characteristics eg sensitivity specificity false negative rate and false positive rate including subgroup analyses
To pool and analyze de-identified data from this previous and future breath analysis studies
Researchers will compare the breath profiles of women with breast cancer and those without to determine whether there are disease-specific patterns that can be leveraged to facilitate breast cancer detection
Women with mammogram-confirmed dense breast tissues undergoing standard-of-care breast cancer screening will be invited to participate Those who provide informed consent will provide one breath sample and fill out a questionnaire about their medical history with help from the research coordinators Breath samples will be collected prior to standard of care biopsy or MRI and patients will be stratified into the case or control group based on their test results
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None