Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT06710067
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Urine Metabolites in the Diagnosis of Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Urine samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-09-27', 'studyFirstSubmitQcDate': '2024-11-25', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease signal detection', 'timeFrame': 'From date of enrollment to the end of sample analysis, up to 100 weeks', 'description': 'Disease signal detection quantification within each disease cohort, compared to normal controls.'}, {'measure': 'Test performance measures', 'timeFrame': 'From date of enrollment to the end of sample analysis, up to 100 weeks', 'description': 'Sensitivity and specificity/false-positive rate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer', 'Small Intestinal Bacterial Overgrowth Syndrome (SIBO)', 'Crohn Disease', 'Celiac Disease']}, 'referencesModule': {'references': [{'pmid': '18479983', 'type': 'BACKGROUND', 'citation': 'Pasikanti KK, Ho PC, Chan EC. Gas chromatography/mass spectrometry in metabolic profiling of biological fluids. J Chromatogr B Analyt Technol Biomed Life Sci. 2008 Aug 15;871(2):202-11. doi: 10.1016/j.jchromb.2008.04.033. Epub 2008 Apr 29.'}, {'pmid': '31092915', 'type': 'BACKGROUND', 'citation': 'Dinges SS, Hohm A, Vandergrift LA, Nowak J, Habbel P, Kaltashov IA, Cheng LL. Cancer metabolomic markers in urine: evidence, techniques and recommendations. Nat Rev Urol. 2019 Jun;16(6):339-362. doi: 10.1038/s41585-019-0185-3.'}, {'pmid': '25541698', 'type': 'BACKGROUND', 'citation': 'Wittmann BM, Stirdivant SM, Mitchell MW, Wulff JE, McDunn JE, Li Z, Dennis-Barrie A, Neri BP, Milburn MV, Lotan Y, Wolfert RL. Bladder cancer biomarker discovery using global metabolomic profiling of urine. PLoS One. 2014 Dec 26;9(12):e115870. doi: 10.1371/journal.pone.0115870. eCollection 2014.'}, {'pmid': '22888338', 'type': 'BACKGROUND', 'citation': 'Fan J, Hong J, Hu JD, Chen JL. Ion chromatography based urine amino Acid profiling applied for diagnosis of gastric cancer. Gastroenterol Res Pract. 2012;2012:474907. doi: 10.1155/2012/474907. Epub 2012 Jul 25.'}, {'pmid': '18433783', 'type': 'BACKGROUND', 'citation': 'Issaq HJ, Nativ O, Waybright T, Luke B, Veenstra TD, Issaq EJ, Kravstov A, Mullerad M. Detection of bladder cancer in human urine by metabolomic profiling using high performance liquid chromatography/mass spectrometry. J Urol. 2008 Jun;179(6):2422-6. doi: 10.1016/j.juro.2008.01.084. Epub 2008 Apr 23.'}], 'seeAlsoLinks': [{'url': 'https://www.luventix.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to validate a non-invasive, urine-based diagnostic technology for the detection and differentiation of various gastrointestinal (GI) diseases.\n\nThis research study intends to enroll participants across a range of demographics and GI disease states including colorectal cancer, small intestinal bacterial overgrowth (SIBO), Crohn\\'s disease, and Celiac disease, collect urine samples and clinical data, and use artificial intelligence and machine learning to build disease-specific models which can identify and differentiate a participants' specific GI disease.\n\nThe main questions it aims to answer are:\n\n1. Does the platform identify a disease signal within each disease cohort, compared to normal controls?\n2. How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are recruited in the United States and/or internationally, with the following order of priority and preference: ·\n\n1. multi-center recruitment and eligibility screen at approximately 5-10 clinical sites, and/or\n2. clinical research organization (CRO) recruitment and eligibility screen, which may include internationally recruited patients and/or\n3. decentralized recruitment via social media sites directing to an online eligibility screen and/or\n4. Biobank/biorepository sourced frozen samples', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years of age at time of enrollment.\n* Able and willing to provide a one-time urine sample and comply with all study procedures for the study.\n* Able to understand the study procedures, able to provide consent to participate in the study, and willing to authorize release of relevant protected health information by consenting to a HIPAA medical release form.\n\nExclusion Criteria:\n\n* Known to be pregnant.\n* A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.'}, 'identificationModule': {'nctId': 'NCT06710067', 'briefTitle': 'Urine Metabolites in the Diagnosis of Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Luventix, Inc.'}, 'officialTitle': 'Observational Study of Urine Metabolites in the Diagnosis of Disease', 'orgStudyIdInfo': {'id': 'Luventix-001'}, 'secondaryIdInfos': [{'id': '20242000', 'type': 'OTHER', 'domain': 'WCG IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Disease Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sarah Marchetti, Practice Manager', 'role': 'CONTACT', 'email': 'sarah.marchetti@uniohp.com', 'phone': '760-783-0441'}, {'name': 'Robert Goldklang, MD', 'role': 'CONTACT'}], 'facility': 'Unio Health Partners (Gastroenterology)', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'La Juana, Study Coordinator', 'role': 'CONTACT', 'email': 'elle20124me@gmail.com', 'phone': '310-829-6789'}, {'name': 'Rahul Dixit, MD', 'role': 'CONTACT'}], 'facility': 'Digestive Health Associates', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer, Patient Care Coordinator', 'role': 'CONTACT', 'email': 'execassistant@westsidegastrocare.com', 'phone': '310-285-3005'}, {'name': 'David Yamini, MD', 'role': 'CONTACT'}], 'facility': 'Westside Gastro Care', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Saxton, Practice Manager, CMA', 'role': 'CONTACT', 'email': 'stephanie.saxton@bassmedicalgroup.com', 'phone': '925-329-3723'}, {'name': 'Rishi Sharma, MD', 'role': 'CONTACT'}], 'facility': 'Bass Medical Group (Gastroenterology)', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}], 'centralContacts': [{'name': 'Catherine Fine, MS, CGC', 'role': 'CONTACT', 'email': 'research@luventix.com', 'phone': '888-404-3143'}], 'overallOfficials': [{'name': 'John Spinosa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luventix, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luventix, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}