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

August 18, 2011
June 23, 2013
August 2011
December 2011   (final data collection date for primary outcome measure)
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)

Not Provided
Complete list of historical versions of study NCT01420588 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Diagnosis of Gastric Lesions With Na-nose
Study of the Exhaled Breath of Patients With Malignant and Benign Lesions With Na-Nose

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:

exhaled breath of volunteers

Non-Probability Sample

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

Stomach Diseases
Not Provided
  • gastric cancer
  • gastritis
  • gastric ulcer
  • normal

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
960
December 2014
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
China,   Latvia
 
NCT01420588
DGLN
Yes
Hu Liu, Anhui Medical University
Anhui Medical University
  • Technion, Israel Institute of Technology
  • University of Latvia
Principal Investigator: Hu Liu, M.D. Department of Oncology,The First Affiliated Hospital of Anhui Medical University, Hefei,China
Anhui Medical University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP