Diagnosis of Gastric Lesions With Na-nose
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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 140 volunteers and 800 patients referred for upper endoscopy or surgery in Latvia were analyzed using a custom-designed array of chemical nanosensors based on organically functionalized gold nanoparticles and carbon nanotubes.Predictive models were built employing discriminant factor analysis (DFA) pattern recognition method. Classification accuracy, sensitivity and specificity were determined using leave-one-out cross-validation. The chemical composition of the breath samples was studied using gas chromatography coupled with mass spectrometry (GC-MS).
| 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 |
- Discrimination between Malignant and Benign Gastric Lesions with Na-nose [ Time Frame: 2 weeks after the collection of breath ] [ Designated as safety issue: Yes ]Alveolar exhaled breath samples collected from 140 volunteers and 800 patients referred for upper endoscopy or surgery in Latvia were analyzed using a custom-designed array of chemical nanosensors based on organically functionalized gold nanoparticles and carbon nanotubes.Predictive models were built employing discriminant factor analysis (DFA) pattern recognition method. Classification accuracy, sensitivity and specificity were determined using leave-one-out cross-validation. The chemical composition of the breath samples was studied using gas chromatography coupled with mass spectrometry (GC-MS).
- Geographical comparison of VOCs between China and Latvia [ Time Frame: 2 weeks after the data analyses ] [ Designated as safety issue: Yes ]To make the comparison between the content of volatile organic compounds in the exhaled breath between the subjects in China and Latvia
Biospecimen Retention: Samples Without DNA
exhaled breath of volunteers
| Estimated Enrollment: | 930 |
| 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 |
140 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
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| 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 | |
| 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: | March 11, 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 May 22, 2013