Diagnosis of Gastric Lesions With Na-nose
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01420588|
Recruitment Status : Recruiting
First Posted : August 19, 2011
Last Update Posted : January 27, 2017
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 or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||960 participants|
|Official Title:||Study of the Exhaled Breath of Patients With Malignant and Benign Lesions With Na-Nose|
|Actual Study Start Date :||August 1, 2011|
|Actual Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 30, 2017|
- Discrimination between Malignant and Benign Gastric Lesions with Na-nose [ Time Frame: 2 weeks after the collection of breath ]
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)
- Geographical comparison of VOCs between China and Latvia [ Time Frame: 2 weeks after the data analyses ]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: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420588
|Department of Oncology, The First Affiliated Hospital of Anhui Medical University||Recruiting|
|Hefei, Anhui, China, 230032|
|Contact: Hu Liu, M.D. +865512922826 firstname.lastname@example.org|
|Principal Investigator: Hu Liu, M.D.|
|Faculty of Medicine, University of Latvia||Recruiting|
|Riga, Latvia, LV1006|
|Contact: Marcis Leja, MD +371-29497500 email@example.com|
|Principal Investigator: Marcis Leja, MD|
|Principal Investigator:||Hu Liu, M.D.||Department of Oncology,The First Affiliated Hospital of Anhui Medical University, Hefei,China|