NCT06710067Recruiting
Urine Metabolites in the Diagnosis of Disease
Observational Study of Urine Metabolites in the Diagnosis of Disease
Source: ClinicalTrials.gov · Last updated 13 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)?
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1250 (estimated)
- First submitted
- 27 Sept 2024
- Start date
- 1 Oct 2024
- Primary completion date
- Sept 2025
- Lead sponsor
- Luventix, Inc.
- Diseases
- Crohn's disease, Colorectal cancer
- NCT number
- NCT06710067
What you commit to
- Study type: Observational
- Planned participants: 1250
- From 1 Oct 2024 to the primary completion date, Sept 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A medical condition which, in the opinion of the Investigator and/or Sponsor, should preclude enrollment in the study.
Other
- Known to be pregnant.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unio Health Partners (Gastroenterology) Coordinator of this site? Confirm its status | Encinitas | United States | Recruiting |
| Digestive Health Associates Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Westside Gastro Care Coordinator of this site? Confirm its status | Santa Monica | United States | Recruiting |
| Bass Medical Group (Gastroenterology) Coordinator of this site? Confirm its status | Walnut Creek | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.