Ignite Creation Date:
2024-05-06 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05173077
Status:
UNKNOWN
Last Update Posted:
2022-02-15
First Post:
2021-10-24
Brief Title:
Hybrid-sensor Breath Analysis for Colorectal Cancer Screening
Sponsor:
University of Latvia
Organization:
University of Latvia
Study Overview
Official Title:
Hybrid-sensor Breath Analysis for Colorectal Cancer Screening HYCOR
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
RECRUITING
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:
HYCOR
Brief Summary:
The aim of this project is to promote the breath volatile marker concept for colorectal cancer CRC screening by advancing developing the application of a novel hybrid analyzer for the purpose
The hybrid analyzer concept is expected to benefit of combining metal-oxide MOX and infrared spectrum IR sensor acquired data The current study will be the first globally to address this concept in CRC detection In addition traditional methods in particular gas chromatography coupled to mass spectrometry GC-MS will be used to address the biological relevance of the VOCs emission from cancer tissue and will assist in further advances of the hybrid-sensing approach
The hybrid analyzer concept is expected to benefit of combining metal-oxide MOX and infrared spectrum IR sensor acquired data The current study will be the first globally to address this concept in CRC detection In addition traditional methods in particular gas chromatography coupled to mass spectrometry GC-MS will be used to address the biological relevance of the VOCs emission from cancer tissue and will assist in further advances of the hybrid-sensing approach
Detailed Description:
For addressing the aims of the project four specific research objectives have been set
1 To identify cancer-related VOCs emitted by the CRC tissue via the comparison of VOCs emitted from cancer tissue with VOCs emitted by non-cancerous tissue ex vivo surgery material by GC-MS
2 To identify the VOCs differentiating human breath from CRC patients and controls by GC-MS as well as compare the chemical signature of CRC patients breath to the chemical signature of cancer tissue
3 To evaluate the performance of the set of sensors in the hybrid analyzer and the performance of particular sensors for detecting CRC to develop and validate a mathematical model for CRC detection
4 To validate the hybrid analyzer in real-life CRC screening settings ie versus the generally accepted CRC screening approach of faecal occult blood detection
5 To compare faecal microbiome between CRC group and control
The scientific results to be obtained during the current project are expected to elucidate the origin and metabolism of volatile biomarkers of CRC This achievement in turn will facilitate the implementation of a new screening test based on the newly developed hybrid analyser into medical practice
Identification of the VOCs patterns by the sensor array for CRC patients when compared to controls Addressing these objectives will allow an in-depth understanding of the physiological background for exhaled VOCs in CRC patients and facilitate the development of technologies able to identify the disease and its precursors from an exhaled breath sample
1 To identify cancer-related VOCs emitted by the CRC tissue via the comparison of VOCs emitted from cancer tissue with VOCs emitted by non-cancerous tissue ex vivo surgery material by GC-MS
2 To identify the VOCs differentiating human breath from CRC patients and controls by GC-MS as well as compare the chemical signature of CRC patients breath to the chemical signature of cancer tissue
3 To evaluate the performance of the set of sensors in the hybrid analyzer and the performance of particular sensors for detecting CRC to develop and validate a mathematical model for CRC detection
4 To validate the hybrid analyzer in real-life CRC screening settings ie versus the generally accepted CRC screening approach of faecal occult blood detection
5 To compare faecal microbiome between CRC group and control
The scientific results to be obtained during the current project are expected to elucidate the origin and metabolism of volatile biomarkers of CRC This achievement in turn will facilitate the implementation of a new screening test based on the newly developed hybrid analyser into medical practice
Identification of the VOCs patterns by the sensor array for CRC patients when compared to controls Addressing these objectives will allow an in-depth understanding of the physiological background for exhaled VOCs in CRC patients and facilitate the development of technologies able to identify the disease and its precursors from an exhaled breath sample
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