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RecruitingObservational

Observational Study of Urine Metabolites in the Diagnosis of Disease

NCT ID: NCT06710067Sponsor: Luventix, Inc.Last updated: 2024-12-13

Summary

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. 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)?

Arms & interventions

Outcome measures

Primary

  • Disease signal detection

    Disease signal detection quantification within each disease cohort, compared to normal controls.

    Time frame: From date of enrollment to the end of sample analysis, up to 100 weeks

  • Test performance measures

    Sensitivity and specificity/false-positive rate

    Time frame: From date of enrollment to the end of sample analysis, up to 100 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
Inclusion Criteria: * Age ≥ 18 years of age at time of enrollment. * 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: * Known to be pregnant. * A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.

Study locations (4)

Unio Health Partners (Gastroenterology)

Encinitas, California, 92024

Recruiting
Sarah Marchetti, Practice Manager · Contact
760-783-0441sarah.marchetti@uniohp.com
Robert Goldklang, MD · Contact

Digestive Health Associates

Santa Monica, California, 90404

Recruiting
La Juana, Study Coordinator · Contact
310-829-6789elle20124me@gmail.com
Rahul Dixit, MD · Contact

Westside Gastro Care

Santa Monica, California, 90404

Recruiting
Jennifer, Patient Care Coordinator · Contact
310-285-3005execassistant@westsidegastrocare.com
David Yamini, MD · Contact

Bass Medical Group (Gastroenterology)

Walnut Creek, California, 94598

Recruiting
Stephanie Saxton, Practice Manager, CMA · Contact
925-329-3723stephanie.saxton@bassmedicalgroup.com
Rishi Sharma, MD · Contact

References

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  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
Urine Metabolites in the Diagnosis of Disease | Cancerify