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Study of the Exhaled Breath of Patients With Malignant and Benign Lesions With Na-Nose


N/A
18 Years
75 Years
Open (Enrolling)
Both
Stomach Diseases

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Trial Information

Study of the Exhaled Breath of Patients With Malignant and Benign Lesions With Na-Nose


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

Discrimination between Malignant and Benign Gastric Lesions with Na-nose

Outcome Description:

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)

Outcome Time Frame:

2 weeks after the collection of breath

Safety Issue:

Yes

Principal Investigator

Hu Liu, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

China: Ministry of Health

Study ID:

DGLN

NCT ID:

NCT01420588

Start Date:

August 2011

Completion Date:

December 2014

Related Keywords:

  • Stomach Diseases
  • Oncologic Investigations
  • Gastric Diseases
  • Gastric Cancer
  • Gastric Ulcer
  • Breath Analysis
  • Volatile Biomarkers
  • Nanosensors Array
  • Discriminant Factor Analysis
  • GC-MS
  • Breath Tests
  • Stomach Diseases

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