Diagnosis of Gastric Lesions From Exhaled Breath and Saliva

NCT01420588 | Completed DMC

• 1 other identifier: DGLES
• Study Type: observational
• Target: 1,000
• Locations: 2 countries
• Sites: 2

Brief Summary

The investigators study the feasibility of a novel method in oncology based on breath analysis with a nanosensors array for identifying gastric diseases. Alveolar exhaled breath samples collected from volunteers referred for upper endoscopy or surgery are analyzed using a custom-designed array of chemical nanosensors based on organically functionalized gold nanoparticles and carbon nanotubes. Predictive models are built employing discriminant factor analysis (DFA) pattern recognition method. Classification accuracy, sensitivity and specificity are determined using leave-one-out cross-validation or an independent blind test set. The chemical composition of the breath samples is studied using gas chromatography coupled with mass spectrometry (GC-MS). A pilot study is conducted first (enlistment of 160 subjects at the Department of Oncology, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.) The pilot study is followed by a large-scale clinical trial to confirm the preliminary results of the Chinese pilot study (enlistment of 800 subjects at the Digestive Diseases Centre GASTRO, Riga East University Hospital, 6 Linezera iela, LV1006 Riga, Latvia). 25% of the samples are used as independent blind test set. The samples are blinded by the medical team and are not disclosed until prediction of blind sample identity is complete. To further prove the diagnosis of GC from exhaled breath and seek the interrelationship among Breathomics, metabolomics and transcriptomics, saliva samples from about 200 patients are collected from volunteers referred for upper endoscopy or surgery are analyzed using Ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS). Simultaneously, RNA sequencing are preformed on gastric cancer tissue samples and paracancerous tissue samples collected from same group of volunteers. The data of salivary metabonomics and transcriptomics were integrated and analyzed on the on Kyoto Encyclopedia of Genes and Genomes to confirm the diagnostic validity of salivary metabonomics.

Conditions

Stomach Diseases

Keywords

Oncologic Investigations; Gastric Diseases; Gastric Cancer; Gastric Ulcer; Breath Analysis; Volatile Biomarkers; Nanosensors Array; Discriminant Factor Analysis; GC-MS; Breath Tests; UHPLC; Salivia

Outcome Measures

Primary Outcomes (1)

• Discrimination between Malignant and Benign Gastric Lesions with Na-nose

  Proof-of-concept: Alveolar exhaled breath samples collected from 160 subjects referred for upper endoscopy at The First Affiliated Hospital of Anhui Medical University are analyzed using a custom-designed array of chemical nanosensors. Predictive models are built employing discriminant factor analysis (DFA). Classification accuracy, sensitivity and specificity were determined using leave-one-out cross-validation. The chemical composition is studied using gas chromatography coupled with mass spectrometry (GC-MS). Confirmation of proof-of-concept: Alveolar exhaled breath samples collected from 800 subjects referred for upper endoscopy at Riga East University Hospital are analyzed as was used in the pilot study. Predictive models are built as in the pilot study,using a training set of only 75% of the samples. Classification accuracy, sensitivity and specificity are determined using an independent blind test set (25% of the samples)

  2 weeks after the collection of breath

Secondary Outcomes (1)

• Geographical comparison of VOCs between China and Latvia

  2 weeks after the data analyses

Other Outcomes (1)

• Proof seeking from metabolomics and transcriptomics

  2 weeks after the data analyses

Study Arms (4)

gastric cancer

gastritis

gastric ulcer

normal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

160 volunteers who undergo gastroscopy examination in The First Affiliated Hospital of Anhui Medical University,Hefei,China and 800 patients with dyspeptic symptoms referred for upper endoscopy or patients suspected for gastric cancer referred for surgery in the clinical sites of University of Latvia (Riga East University hospital and/or Digestive Diseases Centre GASTRO), Riga, Latvia

You may qualify if:

• years
• Gastric cancer, gastric ulcer, gastritis,
• No previous adjuvant treatment (surgery, radiotherapy, chemotherapy)
• Gastric lesions are diagnosed by gastroendoscopy and histopathologic.
• ECOG \< 2

You may not qualify if:

• Other palliative chemotherapy and radiotherapy for this cancer
• Other cancer
• diabetes , Fatty liver
• Autoimmune disease
• Ventilation and transaired function obstacle

Sponsors & Collaborators

• Anhui Medical University: lead
• Technion, Israel Institute of Technology: collaborator
• University of Latvia: collaborator

Study Sites (2)

Department of Oncology, The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230032, China

Location

Faculty of Medicine, University of Latvia

Riga, LV1006, Latvia

Location

Related Publications (4)

• Peng G, Tisch U, Adams O, Hakim M, Shehada N, Broza YY, Billan S, Abdah-Bortnyak R, Kuten A, Haick H. Diagnosing lung cancer in exhaled breath using gold nanoparticles. Nat Nanotechnol. 2009 Oct;4(10):669-73. doi: 10.1038/nnano.2009.235. Epub 2009 Aug 30.

  PMID: 19809459 BACKGROUND

• Xu ZQ, Broza YY, Ionsecu R, Tisch U, Ding L, Liu H, Song Q, Pan YY, Xiong FX, Gu KS, Sun GP, Chen ZD, Leja M, Haick H. A nanomaterial-based breath test for distinguishing gastric cancer from benign gastric conditions. Br J Cancer. 2013 Mar 5;108(4):941-50. doi: 10.1038/bjc.2013.44.

  PMID: 23462808 RESULT

• 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.

  PMID: 25869737 RESULT

• Bao C, Xiang L, Murtazt A, Wang Y, Hu X, Wang S, Bi Y, Liu H, Zhang W. Salivary metabolic profile landscape for gastric cancer screening: a metabolomic approach. Cancer Cell Int. 2025 Dec 8;25(1):435. doi: 10.1186/s12935-025-04107-z.

  PMID: 41361300 DERIVED

Biospecimen

Retention: NONE RETAINED

exhaled breath of volunteers; saliva; tissue

MeSH Terms

Conditions

Stomach Diseases; Stomach Neoplasms; Stomach Ulcer

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases

Study Officials

• Hu Liu, M.D.

  The First Affiliated Hospital of Anhui Medical University, Hefei,China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 19, 2011
• Study Start: August 1, 2011
• Primary Completion: May 1, 2018
• Study Completion: January 30, 2020
• Last Updated: May 8, 2020

Record last verified: 2020-05

Locations

LA (1); CN (1)