Urine Metabolites in the Diagnosis of Disease

Last updated: December 11, 2024
Sponsor: Luventix, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Rectal Cancer

Colon Cancer; Rectal Cancer

Treatment

N/A

Clinical Study ID

NCT06710067
Luventix-001
20242000
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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)?

Eligibility Criteria

Inclusion

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 studyprocedures for the study.

  • Able to understand the study procedures, able to provide consent to participate inthe study, and willing to authorize release of relevant protected health informationby consenting to a HIPAA medical release form.

Exclusion

Exclusion Criteria:

  • Known to be pregnant.

  • A medical condition which, in the opinion of the Investigator and/or Sponsor, shouldpreclude enrollment in the study.

Study Design

Total Participants: 1250
Study Start date:
October 01, 2024
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Unio Health Partners (Gastroenterology)

    Encinitas, California 92024
    United States

    Active - Recruiting

  • Digestive Health Associates

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Westside Gastro Care

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Bass Medical Group (Gastroenterology)

    Walnut Creek, California 94598
    United States

    Active - Recruiting

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