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出境医 / 临床实验 / Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach (VOGAS)

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

Study Description
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.


Condition or disease Intervention/treatment
Gastric Cancer Atrophic Gastritis Gastric Dysplasia H.Pylori Infection Device: Breath sampling for VOC detection Procedure: Surgery material collection for VOC headspace analysis Diagnostic Test: Upper endoscopy Diagnostic Test: Microbiota testing

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
Layout table for study information
Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2026
Arms and Interventions
Group/Cohort Intervention/treatment
Gastric cancer patients undergoing surgery
Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management
 Device: Breath sampling for VOC detection
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 Name: Serum, plasma sampling for group description and stratification

Procedure: Surgery material collection for VOC headspace analysis
Only for gastric cancer patients undergoing surgery (Group 1)

Diagnostic Test: Upper endoscopy
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 Name: Histological and microbial evaluation of biopsy samples and gastric content

Diagnostic Test: Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Gastric cancer patients
Patients with histologically confirmed gastric cancer (adenocarcinoma)
 Device: Breath sampling for VOC detection
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 Name: Serum, plasma sampling for group description and stratification

Diagnostic Test: Upper endoscopy
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 Name: Histological and microbial evaluation of biopsy samples and gastric content

Diagnostic Test: Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Control group patients without gastric cancer
Patients without gastric malignant disease according to data obtained in upper endoscopy
 Device: Breath sampling for VOC detection
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 Name: Serum, plasma sampling for group description and stratification

Diagnostic Test: Upper endoscopy
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 Name: Histological and microbial evaluation of biopsy samples and gastric content

Diagnostic Test: Microbiota testing
Faecal and gastric contents and biopsy samples for 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
 Device: Breath sampling for VOC detection
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 Name: Serum, plasma sampling for group description and stratification

Diagnostic Test: Upper endoscopy
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 Name: Histological and microbial evaluation of biopsy samples and gastric content

Diagnostic Test: Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Patients with dyspeptic symptoms
Patients with dyspeptic symptoms or other complains being referred for upper endoscopy (Chile)
 Device: Breath sampling for VOC detection
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 Name: Serum, plasma sampling for group description and stratification

Diagnostic Test: Upper endoscopy
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 Name: Histological and microbial evaluation of biopsy samples and gastric content

Diagnostic Test: Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Characteristic VOC pattern identification for gastric precancerous lesion detection [ 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

  2. Identification of the best-performing sensors [ Time Frame: 3 years following initiation of patient recruitment ]
    Comparative analysis between the performance of different sensor performance in target disease identification

  3. Gut microbiota analysis in relation to breath VOCs [ 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


Other Outcome Measures:
  1. Confounding factor analysis [ Time Frame: 3 years following initiation of patient recruitment ]
    The role of confounding factors will be addressed to address their role in VOC emission


Biospecimen Retention:   Samples With DNA
Exhaled air samples being stored in specific adsorbent media Plasma/serum samples for group stratification Biopsy samples from stomach for histological assessment and microbiota analysis Gastric content samples for GC-MS and microbiota analysis Faecal samples for occult blood testing and microbiota analysis

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Marcis Leja, MD, PhD +37129497500 marcis.leja@lu.lv
Contact: Daiga Santare, MD, PhD +37129221107 daiga.santare@lu.lv

Locations
Layout table for location information
Brazil
A.C.Camargo Cancer Center
São Paulo, Brazil
Contact: Emmanuel Dias Neto, MD, PhD       emmanuel@accamargo.org.br   
Chile
Pontificia Universidad Catolica de Chile
Santiago, Chile
Colombia
Centro Javeriano de Oncología, San Ignacio University Hospital
Bogotá, Colombia
Contact: Raul Murillo, MD, PhD       raulhmurillo@yahoo.com   
Latvia
Institute of Clinical and Preventive Medicine, University of Latvia
Riga, Latvia, LV1050
Contact: Marcis Leja, MD, PhD    +37129497500    marcis.leja@lu.lv   
Contact: Daiga Santare, MD, PhD    +37129221107    daiga.santare@lu.lv   
Ukraine
National Cancer Institute of Ukraine
Kiev, Ukraine
Contact: Andrii Lukashenko, MD, PhD       mail.onco@gmail.com   
Sponsors and Collaborators
University of Latvia
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
Investigators
Layout table for investigator information
Principal Investigator: Hossam Haick, PhD TECHNION, Israel Institute for Technology
Tracking Information
First Submitted Date July 12, 2019
First Posted Date July 16, 2019
Last Update Posted Date July 18, 2019
Estimated Study Start Date August 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 12, 2019)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 12, 2019)
  • Characteristic VOC pattern identification for gastric precancerous lesion detection [ 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
  • Identification of the best-performing sensors [ Time Frame: 3 years following initiation of patient recruitment ]
    Comparative analysis between the performance of different sensor performance in target disease identification
  • Gut microbiota analysis in relation to breath VOCs [ 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 12, 2019) 		Confounding factor analysis [ Time Frame: 3 years following initiation of patient recruitment ]
The role of confounding factors will be addressed to address their role in VOC emission
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
Official Title Screening of Gastric Cancer Via Breath Volatile Organic Compounds by Hybrid Sensing Approach
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Exhaled air samples being stored in specific adsorbent media Plasma/serum samples for group stratification Biopsy samples from stomach for histological assessment and microbiota analysis Gastric content samples for GC-MS and microbiota analysis Faecal samples for occult blood testing and microbiota analysis
Sampling Method Non-Probability Sample
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
Condition
  • Gastric Cancer
  • Atrophic Gastritis
  • Gastric Dysplasia
  • H.Pylori Infection
Intervention
  • Device: Breath sampling for VOC detection
    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 Name: Serum, plasma sampling for group description and stratification
  • Procedure: Surgery material collection for VOC headspace analysis
    Only for gastric cancer patients undergoing surgery (Group 1)
  • Diagnostic Test: Upper endoscopy
    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 Name: Histological and microbial evaluation of biopsy samples and gastric content
  • Diagnostic Test: Microbiota testing
    Faecal and gastric contents and biopsy samples for microbiota testing
Study Groups/Cohorts
  • Gastric cancer patients undergoing surgery
    Patients with histologically confirmed gastric cancer (adenocarcinoma) planned for surgical management
    Interventions:
    • 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)
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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)
    Interventions:
    • Device: Breath sampling for VOC detection
    • Diagnostic Test: Upper endoscopy
    • Diagnostic Test: Microbiota testing
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.
  • Krilaviciute 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.
  • Amal 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.
  • Krilaviciute 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. Review.
  • Leja 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. Review.
  • Leja 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 12, 2019) 		5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Marcis Leja, MD, PhD +37129497500 marcis.leja@lu.lv
Contact: Daiga Santare, MD, PhD +37129221107 daiga.santare@lu.lv
Listed Location Countries Brazil,   Chile,   Colombia,   Latvia,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number NCT04022109
Other Study ID Numbers 824986
lzp-2018/2-0228 ( Other Grant/Funding Number: Latvia Research Council )
KC-L-2017/5 ( Other Grant/Funding Number: Investment and Development Agency of Latvia )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Marcis Leja, University of Latvia
Study Sponsor University of Latvia
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
Investigators
Principal Investigator: Hossam Haick, PhD TECHNION, Israel Institute for Technology
PRS Account University of Latvia
Verification Date July 2019

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