Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04022109
Other study ID # 824986
Secondary ID lzp-2018/2-0228K
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 2026

Study information

Verified date November 2020
Source University of Latvia
Contact Marcis Leja, MD, PhD
Phone +37129497500
Email marcis.leja@lu.lv
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 5000
Est. completion date December 2026
Est. primary completion date December 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


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
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)
Microbiota testing
Faecal and gastric contents and biopsy samples for microbiota testing

Locations

Country Name City State
Brazil A.C.Camargo Cancer Center São Paulo
Chile Pontificia Universidad Catolica de Chile Santiago
Colombia Centro Javeriano de Oncología, San Ignacio University Hospital Bogotá
Latvia Institute of Clinical and Preventive Medicine, University of Latvia Riga
Ukraine National Cancer Institute of Ukraine Kiev

Sponsors (12)

Lead Sponsor Collaborator
University of Latvia AC Camargo Cancer Center, Hospital Universitario San Ignacio, JLM Innovation GmbH, National Cancer Institute of Ukraine, Pontificia Universidad Catolica de Chile, Technion, Israel Institute of Technology, Universidad de Pamplona, Universitaet Innsbruck, University of Ulm, Uppsala University, VTT Technical Research Centre of Finland

Countries where clinical trial is conducted

Brazil,  Chile,  Colombia,  Latvia,  Ukraine, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Confounding factor analysis The role of confounding factors will be addressed to address their role in VOC emission 3 years following initiation of patient recruitment
Primary Characteristic VOC pattern identification for gastric cancer detection The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected 2 years following initiation of patient recruitment
Primary Specific chemistry identification in the exhaled breath Identification of specific chemistries (GC-MS analysis) originating from gastric cancer 2 years following initiation of patient recruitment
Secondary Characteristic VOC pattern identification for gastric precancerous lesion detection The characteristic VOC pattern based on sensor analysis and its performance indicators will be detected 2.5 years following initiation of patient recruitment
Secondary Identification of the best-performing sensors Comparative analysis between the performance of different sensor performance in target disease identification 3 years following initiation of patient recruitment
Secondary 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 3 years following initiation of patient recruitment
See also
  Status Clinical Trial Phase
Recruiting NCT05551416 - The EpiGASTRIC/EDGAR Project: New Strategies for the Early Detection and Prevention of Gastric Cancer
Completed NCT05518929 - Hypoxia During Gastroenterological Endoscope Procedures Sedated With Ciprofol In Overweight Or Obesity Patients Phase 4
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT03219593 - Apatinib as the First-Line Therapy in Elderly Locally Advanced or Metastatic Gastric Cancer Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT05536102 - The Effectiveness and Safety of XELOX and Tislelizumab + PLD for Resectable Gastric Cancer (LidingStudy) Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Active, not recruiting NCT04082364 - Combination Margetuximab, Retifanlimab, Tebotelimab, and Chemotherapy Phase 2/3 Trial in HER2+ Gastric/GEJ Cancer Phase 2/Phase 3
Withdrawn NCT03766607 - Trastuzumab Beyond Progression in HER2 Positive Metastatic Gastric Cancer Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Completed NCT01924533 - Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer. Phase 3
Terminated NCT01641939 - A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer Phase 2/Phase 3
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Active, not recruiting NCT04908813 - Study of HLX22 in Combanition With Trastuzumab and Chemotherapy Versus Placebo in Combination With Trastuzumab and Chemotherapy for Treatment of Locally Advanced or Metastatic Gastric Cancer Phase 2
Active, not recruiting NCT04249739 - Pembrolizumab + Capecitabine/Oxaliplatin (CapeOx) -HER2 Nagative and Pembrolizumab + Trastuzumab + Cisplatin/Capecitabine HER2 Positive Phase 2
Recruiting NCT05514158 - To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Disitamab Vedotin Combined With RC98 in the Treatment of Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer (Including AEG) Phase 1
Recruiting NCT04931654 - A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer Phase 1/Phase 2
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2