Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1250 participants
OBSERVATIONAL
2024-10-01
2026-09-30
Brief Summary
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This 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.
The main questions it aims to answer are:
1. Does the platform identify a disease signal within each disease cohort, compared to normal controls?
2. How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Disease Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Able and willing to provide a one-time urine sample and comply with all study procedures for the study.
* 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.
Exclusion Criteria
* A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.
18 Years
ALL
Yes
Sponsors
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Luventix, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Spinosa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Luventix, Inc.
Locations
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Unio Health Partners (Gastroenterology)
Encinitas, California, United States
Digestive Health Associates
Santa Monica, California, United States
Westside Gastro Care
Santa Monica, California, United States
Bass Medical Group (Gastroenterology)
Walnut Creek, California, United States
Countries
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Central Contacts
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Facility Contacts
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Sarah Marchetti, Practice Manager
Role: primary
Robert Goldklang, MD
Role: backup
La Juana, Study Coordinator
Role: primary
Rahul Dixit, MD
Role: backup
Jennifer, Patient Care Coordinator
Role: primary
David Yamini, MD
Role: backup
Stephanie Saxton, Practice Manager, CMA
Role: primary
Rishi Sharma, MD
Role: backup
References
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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.
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.
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.
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.
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.
Related Links
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Related Info
Other Identifiers
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20242000
Identifier Type: OTHER
Identifier Source: secondary_id
Luventix-001
Identifier Type: -
Identifier Source: org_study_id