Urine Metabolites in the Diagnosis of Disease

NCT06710067 | Recruiting

• 2 other identifiers: Luventix-00120242000
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 4

Brief 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. 1.Does the platform identify a disease signal within each disease cohort, compared to normal controls?
2. 2.How well does the test perform (e.g. sensitivity and specificity/false-positive rate)?

Conditions

Colorectal Cancer; Small Intestinal Bacterial Overgrowth Syndrome (SIBO); Crohn Disease; Celiac Disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Disease Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Known to be pregnant.
• A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.

Sponsors & Collaborators

• Luventix, Inc.: lead

Study Sites (4)

Unio Health Partners (Gastroenterology)

Encinitas, California, 92024, United States

RECRUITING

Digestive Health Associates

Santa Monica, California, 90404, United States

RECRUITING

Westside Gastro Care

Santa Monica, California, 90404, United States

RECRUITING

Bass Medical Group (Gastroenterology)

Walnut Creek, California, 94598, United States

RECRUITING

Related Publications (5)

• 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: 18479983 BACKGROUND

• 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: 31092915 BACKGROUND

• 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: 25541698 BACKGROUND

• 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: 22888338 BACKGROUND

• 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.

  PMID: 18433783 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples

MeSH Terms

Conditions

Colorectal Neoplasms; Crohn Disease; Celiac Disease

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• John Spinosa, MD, PhD

  Luventix, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Fine, MS, CGC

CONTACT

888-404-3143; research@luventix.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: November 29, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)