Clinical trial NCT06710067: Urine Metabolites in the Diagnosis of Disease
Official title: Observational Study of Urine Metabolites in the Diagnosis of Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
Crohn Disease
Celiac Disease
Lead sponsor: Luventix, Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-29
Enrollment: 1250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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\&#39;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)?


Eligibility criteria: 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.

Primary outcomes:
measure: Disease signal detection
timeFrame: From date of enrollment to the end of sample analysis, up to 100 weeks
measure: Test performance measures
timeFrame: From date of enrollment to the end of sample analysis, up to 100 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Unio Health Partners (Gastroenterology)
state: California
city: Santa Monica
country: United States
facility: Digestive Health Associates
state: California
city: Santa Monica
country: United States
facility: Westside Gastro Care
state: California
city: Walnut Creek
country: United States
facility: Bass Medical Group (Gastroenterology)
state: California
Study officials:
affiliation: Luventix, Inc.
name: John Spinosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.