Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499077
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-04
Brief Title:
Non-invasive Detection of Breast Cancer by Breath Analysis
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Study Overview
Official Title:
Non-invasive Detection of Breast Cancer by Mass-spectrometry-based Profiling of Exhaled Breath
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
BreathBC
Brief Summary:
The goal of this prospective observational study is to compare the exhaled breath profiles of patient with invasive breast cancer and control subjects in the perspective of a diagnostic application in oncology
The main question it aims to answer is whether the exhaled breath profile of breast cancer patients can be discriminate from the exhaled breath of control subjects
Participants to the study are recruited in a first discovery series including about 500 subjects and in a following independent validation series including more than 400 subjects Breath samples are collected in a dedicated room using sampling bags and following anti-Covid-19 measures Only authorized personnel could access the sampling room which was equipped with a HEPA Filter air purification system Sampling bags are made of Nalophan tubular foil and 2 taps one in which the study participant inflated with their breath and sealed after use while the second is used to introduce breath samples into the analyzer Bags are sterilized with the Sterrad system with H2O2 vapors before use To contain the potentially infectious particulate included in the participant exhaled breath an electrostatic filter is mounted on the tap of the bag used to inflate it with breath All participants are supplied with a leaflet explaining aims and technicalclinical information of the study At each breath sampling study participants are asked not to smoke eat drink except for water brush their teeth or use lipstick for at least 2 h before breath collection to minimize the presence of contaminant molecules in exhaled breath
Breath profiling is performed by mass spectrometry analysis using an untargeted approach Breath samples are profiled by Secondary Electrospray ionization - High resolution Mass Spectrometry SESI-HR-MS using a high resolution instrumentation LTQ Orbitrap EliteThermo Fisher Scientific equipped with a SuperSESI ionization source Fossiliontech
Data analysis is based on our previous work MartÃnez-Lozano el al 2015 J Breath Res 9031001 and will be implemented with machine learning and other Artificial Intelligence AI methods
Once all the breath profiles will be collected and analysed researchers will compare data from patient with breast cancer and data from tumor-free subjects to identify methods and patterns able to specifically identify the pathological breath samples and discriminate them from the control breath samples
The main question it aims to answer is whether the exhaled breath profile of breast cancer patients can be discriminate from the exhaled breath of control subjects
Participants to the study are recruited in a first discovery series including about 500 subjects and in a following independent validation series including more than 400 subjects Breath samples are collected in a dedicated room using sampling bags and following anti-Covid-19 measures Only authorized personnel could access the sampling room which was equipped with a HEPA Filter air purification system Sampling bags are made of Nalophan tubular foil and 2 taps one in which the study participant inflated with their breath and sealed after use while the second is used to introduce breath samples into the analyzer Bags are sterilized with the Sterrad system with H2O2 vapors before use To contain the potentially infectious particulate included in the participant exhaled breath an electrostatic filter is mounted on the tap of the bag used to inflate it with breath All participants are supplied with a leaflet explaining aims and technicalclinical information of the study At each breath sampling study participants are asked not to smoke eat drink except for water brush their teeth or use lipstick for at least 2 h before breath collection to minimize the presence of contaminant molecules in exhaled breath
Breath profiling is performed by mass spectrometry analysis using an untargeted approach Breath samples are profiled by Secondary Electrospray ionization - High resolution Mass Spectrometry SESI-HR-MS using a high resolution instrumentation LTQ Orbitrap EliteThermo Fisher Scientific equipped with a SuperSESI ionization source Fossiliontech
Data analysis is based on our previous work MartÃnez-Lozano el al 2015 J Breath Res 9031001 and will be implemented with machine learning and other Artificial Intelligence AI methods
Once all the breath profiles will be collected and analysed researchers will compare data from patient with breast cancer and data from tumor-free subjects to identify methods and patterns able to specifically identify the pathological breath samples and discriminate them from the control breath samples
Detailed Description:
None
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