Gastric CancerVOGASNCT04022109
Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
An observational study of Gastric Cancer and Atrophic Gastritis, run by University of Latvia at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Atrophic Gastritis, Gastric Dysplasia
- What is being tested?
- Breath sampling for VOC detection, Surgery material collection for VOC headspace analysis and Upper endoscopy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 5,000 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Nov 2019to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Cancer patient population will be recruited in the major specialized cancer centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil) Control group patients will be recruited in the major specialized endoscopy centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil), most frequently - the same institutions as for cancer patient recruitment General population group (40-64 years) will be predominantly recruited in Latvia from the general population Symptomatic patient validation cohort (Group 5) will be predominantly recruited in Chile from the endoscopy referrals
Who may be able to join
- 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
Who cannot join
- Known other active cancer
- Ventilation problems, airway obstruction
- Unwillingness or inability to co-operate
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
Brazil1 site, 1 recruiting
- Recruiting
A.C.Camargo Cancer Center
São Paulo
Emmanuel Dias Neto, MD, PhD, emmanuel@accamargo.org.br
Chile1 site, 1 recruiting
- Not yet recruiting
Pontificia Universidad Catolica de Chile
Santiago
Robinson Gonzalez, MD, PhD, robgonza@med.puc.cl
Alejandro Corvalan, MD, PhD, corvalan01@gmail.com
Colombia1 site, 1 recruiting
- Not yet recruiting
Centro Javeriano de Oncología, San Ignacio University Hospital
Bogotá
Raul Murillo, MD, PhD, raulhmurillo@yahoo.com
Latvia1 site, 1 recruiting
- Recruiting
Institute of Clinical and Preventive Medicine, University of Latvia
Riga, LV1050
Marcis Leja, MD, PhD, +37129497500, marcis.leja@lu.lv
Daiga Santare, MD, PhD, +37129221107, daiga.santare@lu.lv
Ukraine1 site, 1 recruiting
- Recruiting
National Cancer Institute of Ukraine
Kiev
Andrii Lukashenko, MD, PhD, mail.onco@gmail.com
About this study
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.
Read the 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 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.
- Being tested
- Breath sampling for VOC detection, Surgery material collection for VOC headspace analysis, Upper endoscopy, Microbiota testing
- Keywords
- Volatile organic compounds, Breath testing, Gastric cancer, Atrophic gastritis, Precancerous lesions, Screening, Nanosensor technology, GC-MS
- Medical subject headings
- Stomach Neoplasms, Gastritis, Atrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath sampling for VOC detectionDevice
Also called Serum, plasma sampling for group description and stratification
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
Surgery material collection for VOC headspace analysisProcedure or surgery
Only for gastric cancer patients undergoing surgery (Group 1)
Upper endoscopyDiagnostic test
Also called Histological and microbial evaluation of biopsy samples and gastric content
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)
Microbiota testingDiagnostic test
Faecal and gastric contents and biopsy samples for microbiota testing
| Study group | Role | What they receive |
|---|---|---|
| Gastric cancer patients undergoing surgery | Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management Receives: Device: Breath sampling for VOC detection; Procedure: Surgery material collection for VOC headspace analysis; Diagnostic Test: Upper endoscopy; Diagnostic Test: Microbiota testing | |
| Gastric cancer patients | Patients with histologically confirmed gastric cancer (adenocarcinoma) Receives: Device: Breath sampling for VOC detection; Diagnostic Test: Upper endoscopy; Diagnostic Test: Microbiota testing | |
| Control group patients without gastric cancer | Patients without gastric malignant disease according to data obtained in upper endoscopy Receives: Device: Breath sampling for VOC detection; Diagnostic Test: Upper endoscopy; Diagnostic Test: Microbiota testing | |
| Average risk population | Average risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer Receives: Device: Breath sampling for VOC detection; Diagnostic Test: Upper endoscopy; Diagnostic Test: Microbiota testing | |
| Patients with dyspeptic symptoms | Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile) Receives: Device: Breath sampling for VOC detection; Diagnostic Test: Upper endoscopy; Diagnostic Test: Microbiota testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristic VOC pattern identification for gastric cancer detection
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Measured: 2 years following initiation of patient recruitment
Specific chemistry identification in the exhaled breath
Identification of specific chemistries (GC-MS analysis) originating from gastric cancer
Measured: 2 years following initiation of patient recruitment
Secondary outcomes (3)
Characteristic VOC pattern identification for gastric precancerous lesion detection
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Measured: 2.5 years following initiation of patient recruitment
Identification of the best-performing sensors
Comparative analysis between the performance of different sensor performance in target disease identification
Measured: 3 years following initiation of patient recruitment
Gut microbiota analysis in relation to breath VOCs
Analysis of the role of gastric and faecal microbiota in the origin of VOCs in the exhaled breath
Measured: 3 years following initiation of patient recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Nov 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Latvia
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology, University of Ulm, Uppsala University, JLM Innovation GmbH, Universitaet Innsbruck, Hospital Universitario San Ignacio, Universidad de Pamplona, Pontificia Universidad Catolica de Chile, AC Camargo Cancer Center, National Cancer Institute of Ukraine, VTT Technical Research Centre of Finland
- Responsible party
- Principal investigator, Marcis Leja, University of Latvia
- Investigators
- Hossam Haick, PhD, Principal investigator, TECHNION, Israel Institute for Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022109
- Sponsor's protocol ID
- 824986
- Other IDs
- lzp-2018/2-0228, KC-L-2017/5
- Acronym
- VOGAS
- Status last verified
- Nov 2020
- First submitted
- 12 Jul 2019
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mochalski P, Leja M, Gasenko E, Skapars R, Santare D, Sivins A, Aronsson DE, Ager C, Jaeschke C, Shani G, Mitrovics J, Mayhew CA, Haick H. Ex vivo emission of volatile organic compounds from gastric cancer and non-cancerous tissue. J Breath Res. 2018 Jul 30;12(4):046005. doi: 10.1088/1752-7163/aacbfb.
PubMed 29893713Krilaviciute A, Stock C, Leja M, Brenner H. Potential of non-invasive breath tests for preselecting individuals for invasive gastric cancer screening endoscopy. J Breath Res. 2018 Apr 4;12(3):036009. doi: 10.1088/1752-7163/aab5be.
PubMed 29528036Amal H, Leja M, Funka K, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Haick H. Detection of precancerous gastric lesions and gastric cancer through exhaled breath. Gut. 2016 Mar;65(3):400-7. doi: 10.1136/gutjnl-2014-308536. Epub 2015 Apr 13.
PubMed 25869737Krilaviciute A, Heiss JA, Leja M, Kupcinskas J, Haick H, Brenner H. Detection of cancer through exhaled breath: a systematic review. Oncotarget. 2015 Nov 17;6(36):38643-57. doi: 10.18632/oncotarget.5938.
PubMed 26440312Leja M, You W, Camargo MC, Saito H. Implementation of gastric cancer screening - the global experience. Best Pract Res Clin Gastroenterol. 2014 Dec;28(6):1093-106. doi: 10.1016/j.bpg.2014.09.005. Epub 2014 Sep 28.
PubMed 25439074Leja M, Amal H, Lasina I, Skapars R, Sivins A, Ancans G, Tolmanis I, Vanags A, Kupcinskas J, Ramonaite R, Khatib S, Bdarneh S, Natour R, Ashkar A, Haick H. Analysis of the effects of microbiome-related confounding factors on the reproducibility of the volatolomic test. J Breath Res. 2016 Jun 24;10(3):037101. doi: 10.1088/1752-7155/10/3/037101.
PubMed 27341527
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
- ClinicalTrials.gov ID
- NCT04022109
- Acronym / sponsor ID
- VOGAS / 824986
- Keywords
- Volatile organic compounds, Breath testing, Gastric cancer, Atrophic gastritis, Precancerous lesions, Screening, Nanosensor technology, GC-MS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of LatviaUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology, University of Ulm, Uppsala University, JLM Innovation GmbH, Universitaet Innsbruck, Hospital Universitario San Ignacio, Universidad de Pamplona, Pontificia Universidad Catolica de Chile, AC Camargo Cancer Center, National Cancer Institute of Ukraine, VTT Technical Research Centre of Finland
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gastric cancer patients undergoing surgery | – | Device: Breath sampling for VOC detection, Procedure: Surgery material collection for VOC headspace analysis, Diagnostic Test: Upper endoscopy, Diagnostic Test: Microbiota testingPatients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management |
| Gastric cancer patients | – | Device: Breath sampling for VOC detection, Diagnostic Test: Upper endoscopy, Diagnostic Test: Microbiota testingPatients with histologically confirmed gastric cancer (adenocarcinoma) |
| Control group patients without gastric cancer | – | Device: Breath sampling for VOC detection, Diagnostic Test: Upper endoscopy, Diagnostic Test: Microbiota testingPatients without gastric malignant disease according to data obtained in upper endoscopy |
| Average risk population | – | Device: Breath sampling for VOC detection, Diagnostic Test: Upper endoscopy, Diagnostic Test: Microbiota testingAverage risk population of both genders aged 40-64 at the time of inclusion lacking alarm symptoms for gastrointestinal cancer |
| Patients with dyspeptic symptoms | – | Device: Breath sampling for VOC detection, Diagnostic Test: Upper endoscopy, Diagnostic Test: Microbiota testingPatients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cancer patient population will be recruited in the major specialized cancer centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil) Control group patients will be recruited in the major specialized endoscopy centres in Europe (Latvia, Ukraine) and Latin America (Colombia, Chile, Brazil), most frequently - the same institutions as for cancer patient recruitment General population group (40-64 years) will be predominantly recruited in Latvia from the general population Symptomatic patient validation cohort (Group 5) will be predominantly recruited in Chile from the endoscopy referrals
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Known other active cancer
- Ventilation problems, airway obstruction
- Unwillingness or inability to co-operate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath sampling for VOC detectionAlso: Serum, plasma sampling for group description and stratificationBreath 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 | Device | Average risk population, Control group patients without gastric cancer, Gastric cancer patients, Gastric cancer patients undergoing surgery, Patients with dyspeptic symptoms |
| Surgery material collection for VOC headspace analysisOnly for gastric cancer patients undergoing surgery (Group 1) | Procedure or surgery | Gastric cancer patients undergoing surgery |
| Upper endoscopyAlso: Histological and microbial evaluation of biopsy samples and gastric contentRoutine 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) | Diagnostic test | Average risk population, Control group patients without gastric cancer, Gastric cancer patients, Gastric cancer patients undergoing surgery, Patients with dyspeptic symptoms |
| Microbiota testingFaecal and gastric contents and biopsy samples for microbiota testing | Diagnostic test | Average risk population, Control group patients without gastric cancer, Gastric cancer patients, Gastric cancer patients undergoing surgery, Patients with dyspeptic symptoms |
Primary outcome
Characteristic VOC pattern identification for gastric cancer detection
Time frame: 2 years following initiation of patient recruitment
The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected
Specific chemistry identification in the exhaled breath
Time frame: 2 years following initiation of patient recruitment
Identification of specific chemistries (GC-MS analysis) originating from gastric cancer
3 secondary outcomes
Characteristic VOC pattern identification for gastric precancerous lesion detection
Time frame: 2.5 years following initiation of patient recruitment
Identification of the best-performing sensors
Time frame: 3 years following initiation of patient recruitment
Gut microbiota analysis in relation to breath VOCs
Time frame: 3 years following initiation of patient recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2021.
- Background: PubMed 29893713Mochalski P, Leja M, Gasenko E, Skapars R, Santare D, Sivins A, Aronsson DE, Ager C, Jaeschke C, Shani G, Mitrovics J, Mayhew CA, Haick H. Ex vivo emission of volatile organic compounds from gastric cancer and non-cancerous tissue. J Breath Res. 2018 Jul 30;12(4):046005. doi: 10.1088/1752-7163/aacbfb.
- Background: PubMed 29528036Krilaviciute A, Stock C, Leja M, Brenner H. Potential of non-invasive breath tests for preselecting individuals for invasive gastric cancer screening endoscopy. J Breath Res. 2018 Apr 4;12(3):036009. doi: 10.1088/1752-7163/aab5be.
- Background: PubMed 25869737Amal H, Leja M, Funka K, Skapars R, Sivins A, Ancans G, Liepniece-Karele I, Kikuste I, Lasina I, Haick H. Detection of precancerous gastric lesions and gastric cancer through exhaled breath. Gut. 2016 Mar;65(3):400-7. doi: 10.1136/gutjnl-2014-308536. Epub 2015 Apr 13.
- Background: PubMed 26440312Krilaviciute A, Heiss JA, Leja M, Kupcinskas J, Haick H, Brenner H. Detection of cancer through exhaled breath: a systematic review. Oncotarget. 2015 Nov 17;6(36):38643-57. doi: 10.18632/oncotarget.5938.
- Background: PubMed 25439074Leja M, You W, Camargo MC, Saito H. Implementation of gastric cancer screening - the global experience. Best Pract Res Clin Gastroenterol. 2014 Dec;28(6):1093-106. doi: 10.1016/j.bpg.2014.09.005. Epub 2014 Sep 28.
- Background: PubMed 27341527Leja M, Amal H, Lasina I, Skapars R, Sivins A, Ancans G, Tolmanis I, Vanags A, Kupcinskas J, Ramonaite R, Khatib S, Bdarneh S, Natour R, Ashkar A, Haick H. Analysis of the effects of microbiome-related confounding factors on the reproducibility of the volatolomic test. J Breath Res. 2016 Jun 24;10(3):037101. doi: 10.1088/1752-7155/10/3/037101.
- Horizon 2020 project VOGAS web-pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hossam Haick, PhD principal investigator
TECHNION, Israel Institute for Technology
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer and Atrophic Gastritis, run by University of Latvia at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil, Chile, Colombia, Latvia, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marcis Leja, MD, PhD (+37129497500, marcis.leja@lu.lv), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristic VOC pattern identification for gastric cancer detection (time frame: 2 years following initiation of patient recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04022109, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2021.