Volatiles in Breath and Headspace Analysis - Diagnostic Markers
NCT03228095 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 3000
Last updated 2018-08-21
Summary
Detection of Volatile Organic Compounds (VOC) directly from tissue by headspace analysis (skin, surgery material, other tissue) and exhaled breath is feasible using affordable user-friendly novel nano-chemo sensors that can accurately be used for screening and monitoring purpose
Conditions
- Tuberculosis
- Gastric Cancer
- Peptic Ulcer
- Atrophic Gastritis
- Intestinal Metaplasia
- Gastric Dysplasia
- Colorectal Cancer
- Colorectal Polyp
- Colorectal Adenoma
- Pancreatic Cancer
- Pancreatitis, Chronic
- Liver Cancer
- Liver Cirrhosis
- Flu, Human
- Other Infectious Diseases
- Inflammatory Bowel Diseases
Interventions
- DIAGNOSTIC_TEST
-
VOC detection in breath and in skin headspace
VOC will be detected in breath with off-line and on-line testing and in skin headspace with off-line testing
- DIAGNOSTIC_TEST
-
Breath sampling
Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose)
- PROCEDURE
-
Upper endoscopy with biopsies
Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing
- PROCEDURE
-
Colonoscopy with biopsies
Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing
- PROCEDURE
-
Whole blood/ Plasma / serum sampling
Whole blood/Plasma/serum sampling will be used to obtain information for group stratification
- DIAGNOSTIC_TEST
-
Faecal sampling
Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis
- PROCEDURE
-
Histological examination of surgical specimen
Routine histological exam for patients undergoing curative or palliative surgery. Indication for surgery are set based on underlying condition. Study does not interfere with decision making for surgical treatment
- DIAGNOSTIC_TEST
-
Headspace analysis for biological material
VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.
Sponsors & Collaborators
-
Technion, Israel Institute of Technology
collaborator OTHER -
Riga East University Hospital
collaborator UNKNOWN -
JLM Innovation GmbH
collaborator UNKNOWN -
University of Latvia
lead OTHER
Principal Investigators
-
Mārcis Leja, PhD, MD · University of Latvia
-
Lelde Lauka, MD · University of Latvia
-
Andra Cīrule, MD · Riga East University Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-07-24
- Primary Completion
- 2019-12-20
- Completion
- 2025-12-31
Countries
- Latvia
Study Locations
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