Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-28 @ 8:07 AM
Study NCT ID:
NCT01291550
Status:
UNKNOWN
Last Update Posted:
2011-02-08
First Post:
2011-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'lastUpdateSubmitDate': '2011-02-07', 'studyFirstSubmitDate': '2011-02-07', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Detecting volatile biomarkers using breath sample'], 'conditions': ['Neurodegenerative Diseases']}, 'referencesModule': {'references': [{'pmid': '23067372', 'type': 'DERIVED', 'citation': "Tisch U, Schlesinger I, Ionescu R, Nassar M, Axelrod N, Robertman D, Tessler Y, Azar F, Marmur A, Aharon-Peretz J, Haick H. Detection of Alzheimer's and Parkinson's disease from exhaled breath using nanomaterial-based sensors. Nanomedicine (Lond). 2013 Jan;8(1):43-56. doi: 10.2217/nnm.12.105. Epub 2012 Oct 15."}]}, 'descriptionModule': {'briefSummary': 'The diagnosis of neurodegenerative conditions and ADHD still mostly relies on clinical symptoms as there are no validated, inexpensive, and simple bio- markers available yet. The purpose of this study is to deliver a proof-of-concept for novel biomarkers to identify neurodegenerative conditions and ADHD based on breath testing.\n\nAlveolar breath will be collected from healthy volunteers, patients with extrapyramidal conditions, patients diagnosed with dementia and from ADHD subjects. The discriminative power of a tailor-made Nanoscale Artificial Nose (™NA-NOSE) containing an array of six nanomaterial-based sensors will be tested. Discriminant factor analysis will be applied to the NA-NOSE signals in order to detect statistically significant differences between the sub-populations, and classification success will be estimated using leave-one-out cross-validation. The identification of NA-NOSE patterns will be supported by analyzing the chemical composition of the breath using gas-chromatography in conjunction with mass-spectrometry (GC-MS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Out patient clinic patients diagnosed with neurodegenerative conditions healthy control and subjects diagnosed with ADHD.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with neurodegenerative conditions\n* Healthy subjects\n* Subjects diagnosed with ADHD'}, 'identificationModule': {'nctId': 'NCT01291550', 'briefTitle': 'Electronic Nose for Diagnosis of Neurodegenerative Diseases Via Breath Samples', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'orgStudyIdInfo': {'id': '0196-09'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nerodegenerative diseases', 'description': 'Patients with parkinsonism and patients with dementia'}, {'label': 'Controls'}, {'label': 'ADHD', 'description': 'Subjects diagnosed with ADHD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31096', 'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Judith Aharon-Peretz, M.D', 'role': 'CONTACT', 'email': 'memory@rambam.health.gov.il', 'phone': '97248543190'}, {'name': 'Michal Levavi, MA.RN', 'role': 'CONTACT'}, {'name': 'Judith Aharon-Peretz, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cognitive Neurology, Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technion, Israel Institute of Technology', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Prof Judith aharon-Peretz', 'oldOrganization': 'Rambam Medica Center'}}}}