Diagnosis of Gastric Lesions With Na-nose

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Anhui Medical University
Sponsor:
Collaborators:
Technion, Israel Institute of Technology
University of Latvia
Information provided by (Responsible Party):
Hu Liu, Anhui Medical University
ClinicalTrials.gov Identifier:
NCT01420588
First received: August 18, 2011
Last updated: June 23, 2013
Last verified: June 2013
  Purpose

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.


Condition
Stomach Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of the Exhaled Breath of Patients With Malignant and Benign Lesions With Na-Nose

Resource links provided by NLM:


Further study details as provided by Anhui Medical University:

Primary Outcome Measures:
  • Discrimination between Malignant and Benign Gastric Lesions with Na-nose [ Time Frame: 2 weeks after the collection of breath ] [ Designated as safety issue: Yes ]

    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)



Secondary Outcome Measures:
  • Geographical comparison of VOCs between China and Latvia [ Time Frame: 2 weeks after the data analyses ] [ Designated as safety issue: Yes ]
    Specifically, to compare the VOCs that distinguish between malignant and benign gastric lesions in the Chinese and Latvian cohorts. The cohorts from China and Latvia are matched in terms of sample size, gender ratio, average age, and smoking habits.


Biospecimen Retention:   Samples Without DNA

exhaled breath of volunteers


Estimated Enrollment: 960
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
gastric cancer
gastritis
gastric ulcer
normal

Detailed Description:

Number of patients that will have a definitive diagnosis and Alveolar exhaled breath samples collected from individuals with Tedlar® bags (Keika Ventures, LLC) after endoscopy.. Two breath samples were collected from each person tested.

Two-bed sorption tubes filled with the following sorbents were used as traps for sample collection with simultaneous preconcentration: 100mg matrix Tenax TA and 50mg matrix Tenax TA (35-60 mesh; purchased from Supelo, Bellefonte, PA). Sorbents were separated by glass wool. The samples were collected at a total flow through sorption trap of 200ml/min.

One sample was used for analysis with the nanosensors array, and the other sample was used for Gas Chromatography coupled with Mass Spectrometry (GC-MS) analysis.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

Inclusion Criteria:

  • 18-75 years
  • Gastric cancer, gastric ulcer, gastritis,
  • No previous adjuvant treatment (surgery, radiotherapy, chemotherapy)
  • Gastric lesions are diagnosed by gastroendoscopy and histopathologic.
  • ECOG < 2

Exclusion Criteria:

  • Other palliative chemotherapy and radiotherapy for this cancer
  • Other cancer
  • diabetes , Fatty liver
  • Autoimmune disease
  • Ventilation and transaired function obstacle
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420588

Locations
China, Anhui
Department of Oncology, The First Affiliated Hospital of Anhui Medical University Recruiting
Hefei, Anhui, China, 230032
Contact: Hu Liu, M.D.    +865512922826    drliuhu@gmail.com   
Principal Investigator: Hu Liu, M.D.         
Latvia
Faculty of Medicine, University of Latvia Recruiting
Riga, Latvia, LV1006
Contact: Marcis Leja, MD    +371-29497500    cei@latnet.lv   
Principal Investigator: Marcis Leja, MD         
Sponsors and Collaborators
Anhui Medical University
Technion, Israel Institute of Technology
University of Latvia
Investigators
Principal Investigator: Hu Liu, M.D. Department of Oncology,The First Affiliated Hospital of Anhui Medical University, Hefei,China
  More Information

Publications:
Responsible Party: Hu Liu, Associated Professor, Anhui Medical University
ClinicalTrials.gov Identifier: NCT01420588     History of Changes
Other Study ID Numbers: DGLN
Study First Received: August 18, 2011
Last Updated: June 23, 2013
Health Authority: China: Ministry of Health

Keywords provided by Anhui Medical University:
Oncologic Investigations
Gastric Diseases
Gastric Cancer
Gastric Ulcer
Breath Analysis
Volatile Biomarkers
Nanosensors Array
Discriminant Factor Analysis
GC-MS
Breath Tests

Additional relevant MeSH terms:
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014