Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04022109
Status:
RECRUITING
Last Update Posted:
2021-07-26
First Post:
2019-07-12
Brief Title:
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Sponsor:
University of Latvia
Organization:
University of Latvia
Study Overview
Official Title:
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Status:
RECRUITING
Status Verified Date:
2020-11
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:
VOGAS
Brief Summary:
The study is aimed to determine the potential of volatile marker testing for gastric cancer screening
The study will be addressing the role of confounding factors including lifestyle factors diet smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers
The study will be addressing the role of confounding factors including lifestyle factors diet smoking as well as addressing the potential role of microbiota in the composition of exhaled volatile markers
Detailed Description:
Patients with established disease gastric cancer precancerous lesions as well as patients investigated for the lesions and having been documented lack of the lesions will be enrolled to the study at clinical sites in Europe Latvia Ukraine and Latin America Colombia Chile Brazil In addition group of persons from general population at average risk for developing the target disease and individuals being referred for upper endoscopy according to clinical indications will be also enrolled
Testing of volatile markers will be conducted by one of two methods 1 gas chromatography coupled to mass spectroscopy GS-MS and 2 sensor technology Various sensors will be used and evaluated for the purpose
The potential sources of volatile organic compounds VOCs in the breath will be addressed by studying VOC emission by using headspace analysis from cancer tissue gastric contents cancer cell cultures and Hpylori
The potential role of gastric and faecal microbiota in the origin of VOCs in the breath will be addressed Metabolome in the circulation will also get correlated to VOCs in the breath and with microbiome
Testing of volatile markers will be conducted by one of two methods 1 gas chromatography coupled to mass spectroscopy GS-MS and 2 sensor technology Various sensors will be used and evaluated for the purpose
The potential sources of volatile organic compounds VOCs in the breath will be addressed by studying VOC emission by using headspace analysis from cancer tissue gastric contents cancer cell cultures and Hpylori
The potential role of gastric and faecal microbiota in the origin of VOCs in the breath will be addressed Metabolome in the circulation will also get correlated to VOCs in the breath and with microbiome
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 |
|---|---|---|---|
| lzp-20182-0228 | OTHER_GRANT | None | None |
| KC-L-20175 | OTHER_GRANT | Investment and Development Agency of Latvia | None |