NCT01420588

Diagnosis of Gastric Lesions From Exhaled Breath and Saliva

Completed Last updated 8 May 2020

What this trial tests

trial in Stomach Diseases in 1,000 participants. Completed in 30 January 2020.

Timeline

1 August 2011

Primary endpoint
1 May 2018

30 January 2020

Quick facts

Lead sponsor	Anhui Medical University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,000
Start date	1 August 2011
Primary completion	1 May 2018
Estimated completion	30 January 2020
Sites	2 locations across China, Latvia

Conditions studied

• Stomach Diseases — all drugs for Stomach Diseases →

Sponsor

Anhui Medical University

Who can join

Adults 18 to 75, any sex, with Stomach Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gold Nanoparticles in Diagnostics and Therapeutics for Human Cancer.
   Singh P, Pandit S, Mokkapati VRSS, Garg A, et al · · 2018 · cited 520× · PMID 29986450 · DOI 10.3390/ijms19071979
2. A Review of Clinical Translation of Inorganic Nanoparticles.
   Anselmo AC, Mitragotri S. · · 2015 · cited 263× · PMID 25956384 · DOI 10.1208/s12248-015-9780-2
3. Nanotechnology in cancer diagnosis: progress, challenges and opportunities.
   Zhang Y, Li M, Gao X, Chen Y, et al · · 2019 · cited 227× · PMID 31847897 · DOI 10.1186/s13045-019-0833-3
4. Detection of precancerous gastric lesions and gastric cancer through exhaled breath.
   Amal H, Leja M, Funka K, Skapars R, et al · · 2016 · cited 131× · PMID 25869737 · DOI 10.1136/gutjnl-2014-308536
5. Gold nanoparticles enlighten the future of cancer theranostics.
   Guo J, Rahme K, He Y, Li LL, et al · · 2017 · cited 125× · PMID 28883725 · DOI 10.2147/ijn.s140772
6. Multifunctional Gold Nanoparticles for Improved Diagnostic and Therapeutic Applications: A Review.
   Sibuyi NRS, Moabelo KL, Fadaka AO, Meyer S, et al · · 2021 · cited 99× · PMID 34866165 · DOI 10.1186/s11671-021-03632-w
7. Current Overview of Metal Nanoparticles' Synthesis, Characterization, and Biomedical Applications, with a Focus on Silver and Gold Nanoparticles.
   Burlec AF, Corciova A, Boev M, Batir-Marin D, et al · · 2023 · cited 93× · PMID 37895881 · DOI 10.3390/ph16101410
8. Multifunctional Gold Nanoparticles in Cancer Diagnosis and Treatment.
   Yang Y, Zheng X, Chen L, Gong X, et al · · 2022 · cited 76× · PMID 35571258 · DOI 10.2147/ijn.s355142