Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01279356
Status:
UNKNOWN
Last Update Posted:
2011-01-28
First Post:
2011-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Volatile Organic Compounds (VOCs) and Liver Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The following biospecimens will be collected: exhaled air and plasma/serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-01-27', 'studyFirstSubmitDate': '2011-01-17', 'studyFirstSubmitQcDate': '2011-01-18', 'lastUpdatePostDateStruct': {'date': '2011-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To establish the validity of VOC analysis in exhaled air to discriminate between liver diseases and non-diseased controls', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'To compare the VOC profiles in exhaled air between various liver diseases', 'timeFrame': '12 months'}, {'measure': 'To compare the VOC analysis before, during and after therapeutic interventions in various liver diseases', 'timeFrame': '12 months'}, {'measure': 'To compare VOC profiles with systemic inflammatory and oxidative stress markers', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Liver diseases', 'Volatile organic compounds', 'Inflammation', 'Oxidative stress', 'non-invasive tests'], 'conditions': ['Liver Diseases']}, 'descriptionModule': {'briefSummary': 'Liver diseases such as non-alcoholic fatty liver disease (NAFLD), alcoholic liver disease (ALD) and viral hepatitis have the potential to progress to cirrhosis and finally hepatocellular carcinoma (HCC). Early diagnosis and treatment of liver diseases is important since progression is likely and is associated with significant morbidity and mortality. However, in daily clinical practice no specific and non-invasive biomarkers are used for the diagnosis and follow-up of patients with liver diseases. It is known that patients with liver diseases produce compounds that can be excreted in breath as a consequence of metabolic processes, inflammation and/or oxidative stress. These are called volatile organic compounds (VOCs). Analysis of VOCs in exhaled air has been reported to provide valuable information in patients with chronic obstructive lung disease (COPD) and inflammatory bowel disease (IBD). Also, in patients with liver disease, exhaled VOCs have been detected.\n\nThe investigators hypothesize that analysis of VOCs in exhaled air of patients with liver diseases can be used for diagnosis and follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include patients with various liver diseases visiting the outpatient clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Established diagnosis of liver diseases based on laboratory, radiological and histological characteristics\n* Age between 18 and 85 years\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Chronic obstructive lung disease, lung cancer, asthma\n* Rheumatoid arthritis'}, 'identificationModule': {'nctId': 'NCT01279356', 'briefTitle': 'Volatile Organic Compounds (VOCs) and Liver Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Analysis of Volatile Organic Compounds in Exhaled Air as a Non-invasive Biomarker for Liver Diseases', 'orgStudyIdInfo': {'id': 'MEC 10-3-088'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with liver diseases of various etiologies', 'description': '* viral hepatitis\n* cholestatic liver diseases\n* auto-immune hepatitis\n* NAFLD\n* ALD\n* sarcoidosis of the liver'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'contacts': [{'name': 'Kirsten Pijls, MD', 'role': 'CONTACT', 'email': 'k.pijls@maastrichtuniversity.nl', 'phone': '+31433882157'}], 'facility': 'Maastricht University Medical Center, Division of Gastroenterology/Hepatology', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Kirsten Pijls, MD', 'role': 'CONTACT', 'email': 'k.pijls@maastrichtuniversity.nl', 'phone': '+31433882157'}], 'overallOfficials': [{'name': 'A Masclee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Prof. dr. A. Masclee', 'oldOrganization': 'Maastricht University Medical Center'}}}}