Urine Metabolites in the Diagnosis of Disease

Observational Study of Urine Metabolites in the Diagnosis of Disease

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)?

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Celiac Disease; Crohn Disease; Small Intestinal Bacterial Overgrowth Syndrome (SIBO)

• Study Type: Observational
• Enrollment (Estimated): 1250

Contacts and Locations

• Study Contact: Name: Catherine Fine, MS, CGC; Phone Number: 888-404-3143; Email: research@luventix.com

Study Locations

• United States
  • California
    • Encinitas, California, United States, 92024
      • Recruiting
      • Unio Health Partners (Gastroenterology)
      • Contact: Sarah Marchetti, Practice Manager; Phone Number: 760-783-0441; Email: sarah.marchetti@uniohp.com
      • Contact: Robert Goldklang, MD
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Digestive Health Associates
      • Contact: La Juana, Study Coordinator; Phone Number: 310-829-6789; Email: elle20124me@gmail.com
      • Contact: Rahul Dixit, MD
    • Santa Monica, California, United States, 90404
      • Recruiting
      • Westside Gastro Care
      • Contact: Jennifer, Patient Care Coordinator; Phone Number: 310-285-3005; Email: execassistant@westsidegastrocare.com
      • Contact: David Yamini, MD
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Bass Medical Group (Gastroenterology)
      • Contact: Stephanie Saxton, Practice Manager, CMA; Phone Number: 925-329-3723; Email: stephanie.saxton@bassmedicalgroup.com
      • Contact: Rishi Sharma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited in the United States and/or internationally, with the following order of priority and preference: ·

1. multi-center recruitment and eligibility screen at approximately 5-10 clinical sites, and/or
2. clinical research organization (CRO) recruitment and eligibility screen, which may include internationally recruited patients and/or
3. decentralized recruitment via social media sites directing to an online eligibility screen and/or
4. Biobank/biorepository sourced frozen samples

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Disease Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease signal detection	Disease signal detection quantification within each disease cohort, compared to normal controls.	From date of enrollment to the end of sample analysis, up to 100 weeks
Test performance measures	Sensitivity and specificity/false-positive rate	From date of enrollment to the end of sample analysis, up to 100 weeks

Collaborators and Investigators

• Sponsor: Luventix, Inc.
• Investigators: Principal Investigator: John Spinosa, MD, PhD, Luventix, Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 27, 2024
• First Submitted That Met QC Criteria: November 25, 2024
• First Posted (Actual): November 29, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 11, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Malabsorption Syndromes; Blind Loop Syndrome; Crohn Disease; Celiac Disease
• Other Study ID Numbers: Luventix-001; 20242000 (Other Identifier: WCG IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No