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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03228095 |
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Date of registration:
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21/07/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Volatiles in Breath and Headspace Analysis - Diagnostic Markers
Volatolome |
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Scientific title:
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Volatile Organic Compounds in Breath and Headspace Analysis - Diagnostic and Monitoring Markers for Diseases |
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Date of first enrolment:
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July 24, 2017 |
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Target sample size:
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3000 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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https://clinicaltrials.gov/show/NCT03228095 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Latvia
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Contacts
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Name:
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Marcis Leja, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Latvia |
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Name:
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Andra Cirule, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Riga East University Hospital |
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Name:
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Lelde Lauka, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Latvia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Informed Consent signed
- Individual with targeted disease/lesion (tuberculosis, gastric cancer, gastric
dysplasia, high/ normal/ low risk gastric lesions, colorectal cancer, high-risk
colorectal lesions, low-risk colorectal adenoma, pancreatic cancer, chronic
pancreatitis, liver cancer, chronic liver disease, other infectious diseases,
oncological diseases of other location)
Exclusion Criteria:
- Informed Consent not signed
- Other active cancer at the time of inclusion for particular study group
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liver Cancer
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Colorectal Polyp
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Inflammatory Bowel Diseases
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Atrophic Gastritis
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Gastric Cancer
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Gastric Dysplasia
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Pancreatitis, Chronic
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Colorectal Adenoma
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Flu, Human
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Liver Cirrhosis
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Pancreatic Cancer
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Tuberculosis
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Other Infectious Diseases
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Colorectal Cancer
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Intestinal Metaplasia
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Peptic Ulcer
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Intervention(s)
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Diagnostic Test: VOC detection in breath and in skin headspace
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Procedure: Histological examination of surgical specimen
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Procedure: Upper endoscopy with biopsies
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Procedure: Whole blood/ Plasma / serum sampling
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Diagnostic Test: Headspace analysis for biological material
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Diagnostic Test: Breath sampling
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Procedure: Colonoscopy with biopsies
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Diagnostic Test: Faecal sampling
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Primary Outcome(s)
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Specific VOC detected
[Time Frame: 2 years]
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Performance of nanoarray sensor testing to detect target lesions and diseases
[Time Frame: At the time of breath sampling]
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Secondary Outcome(s)
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VOC pattern changes following treatment
[Time Frame: At baseline, 3 and/or 6 months after treatment (other time frame according to study group)]
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VOC pattern changes in relapse of disease for early recognition and treatment
[Time Frame: At baseline, 3 and/or 6 months after treatment (other time frame according to study group)]
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Groups of gastrointestinal microbiota correlating to VOCs
[Time Frame: At the time of sampling]
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Specific VOC patterns for target disease or lesion and risk groups
[Time Frame: At the time of breath sampling]
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Secondary ID(s)
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2017/20329
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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