NCT Number: NCT04022109
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
A.C.Camargo Cancer Center, São Paulo, Brazil
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 H.pylori.
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Breath sampling will be performed by using a special sensor device and or GC-MS analysis (by collecting breath samples in adsorbent tubes). Pepsinogen testing will be used in a subgroup to identify serological increased risk for atrophy
Other names: Serum, plasma sampling for group description and stratification
Only for gastric cancer patients undergoing surgery (Group 1)
Routine endoscopic evaluation with a standard biopsy work-up according to updated Sydney system. Additional gastric contents for GC-MS and microbiota analysis in a subgroup. Endoscopy will be used only according to the clinical indications (in Group 4 - according to the results of pepsinogen tests)
Other names: Histological and microbial evaluation of biopsy samples and gastric content
Faecal and gastric contents and biopsy samples for microbiota testing
Time frame: 2 years following initiation of patient recruitment
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Time frame: 2 years following initiation of patient recruitment
Identification of specific chemistries (GC-MS analysis) originating from gastric cancer
Time frame: 2.5 years following initiation of patient recruitment
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Time frame: 3 years following initiation of patient recruitment
Comparative analysis between the performance of different sensor performance in target disease identification
Time frame: 3 years following initiation of patient recruitment
Analysis of the role of gastric and faecal microbiota in the origin of VOCs in the exhaled breath
Time frame: 3 years following initiation of patient recruitment
The role of confounding factors will be addressed to address their role in VOC emission
Contact information is provided by the study sponsor or research team.
Daiga Santare, MD, PhD
CONTACT
Marcis Leja, MD, PhD
CONTACT
University of Latvia
Other
Acronym: VOGAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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