RECRUITING

Urine Metabolites in the Diagnosis of Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)?

Official Title

Observational Study of Urine Metabolites in the Diagnosis of Disease

Quick Facts

Study Start:2024-10-01
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06710067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years of age at time of enrollment.
  2. * Able and willing to provide a one-time urine sample and comply with all study procedures for the study.
  3. * 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.
  1. * Known to be pregnant.
  2. * A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.

Contacts and Locations

Study Contact

Catherine Fine, MS, CGC
CONTACT
888-404-3143
research@luventix.com

Principal Investigator

John Spinosa, MD, PhD
PRINCIPAL_INVESTIGATOR
Luventix, Inc.

Study Locations (Sites)

Unio Health Partners (Gastroenterology)
Encinitas, California, 92024
United States
Bass Medical Group (Gastroenterology)
Walnut Creek, California, 94598
United States

Collaborators and Investigators

Sponsor: Luventix, Inc.

  • John Spinosa, MD, PhD, PRINCIPAL_INVESTIGATOR, Luventix, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2026-09

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

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