Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach (VOGAS)

University of Latvia

Status: Enrolling

Conditions: Atrophic Gastritis; Gastric Cancer; H.Pylori Infection; Gastric Dysplasia

Treatments: Diagnostic Test: Microbiota testing; Device: Breath sampling for VOC detection; Procedure: Surgery material collection for VOC headspace analysis; Diagnostic Test: Upper endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04022109

lzp-2018/2-0228 (Other Grant/Funding Number)

824986

KC-L-2017/5 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with verified gastric cancer (Group 1 & 2)
• Patients undergoing or having undergone upper endoscopy according to clinical indications (Group 3 & 5)
• Average-risk population group aged 40-64 at inclusion without alarm symptoms (Group 4)
• Motivation to participate in the study
• Physical status allowing volatile marker sampling and other procedures within the protocol
• Signed consent

Exclusion criteria

• Known other active cancer
• Ventilation problems, airway obstruction
• Unwillingness or inability to co-operate

Trial design

5,000 participants in 5 patient groups

Gastric cancer patients undergoing surgery

Description:

Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management

Treatment:

Diagnostic Test: Upper endoscopy

Diagnostic Test: Microbiota testing

Procedure: Surgery material collection for VOC headspace analysis

Device: Breath sampling for VOC detection

Gastric cancer patients

Description:

Patients with histologically confirmed gastric cancer (adenocarcinoma)

Treatment:

Diagnostic Test: Upper endoscopy

Diagnostic Test: Microbiota testing

Device: Breath sampling for VOC detection

Control group patients without gastric cancer

Description:

Patients without gastric malignant disease according to data obtained in upper endoscopy

Treatment:

Diagnostic Test: Upper endoscopy

Diagnostic Test: Microbiota testing

Device: Breath sampling for VOC detection

Average risk population

Description:

Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer

Treatment:

Diagnostic Test: Upper endoscopy

Diagnostic Test: Microbiota testing

Device: Breath sampling for VOC detection

Patients with dyspeptic symptoms

Description:

Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile)

Treatment:

Diagnostic Test: Upper endoscopy

Diagnostic Test: Microbiota testing

Device: Breath sampling for VOC detection