Open Actively Recruiting

The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States

About

Brief Summary

A multi-center observational study based at referral centers and community hospitals within the US. Patients' blood will be collected at enrollment for testing with PredictSURE IBD™, which will occur at a later date. Patients will be prospectively followed up for 12 months with clinicians treating according to local standard of care, with a step-up or accelerated step-up regimen. Clinicians and patients will be blinded to the biomarker results.

Study Type
Observational

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
16 Years
Maximum Age
80 Years

Inclusion Criteria:

  • Active UC or CD with typical symptoms in conjunction with at least one objective measure of disease activity: elevated CRP, calprotectin, endoscopic evidence.
  • Not currently receiving systemic therapy* with steroids, immunomodulators or biologics, and at least 7 days since the last steroid dose.
  • Due to be managed using a "step-up" or "accelerated step-up" approach (so will not receive biologics as first line therapy).
  • Aged 16-80 years old. Note, the ideal patients for this study are newly diagnosed patients who are treatment-naïve.

Exclusion Criteria:

  • The presence of any of the following will preclude patient inclusion:
  • Patients with fistulating peri-anal Crohn's disease or active perianal sepsis.
  • Obstructive symptoms and evidence of a fixed stricture on radiology or colonoscopy.
  • Patients who are scheduled to start on "top-down" therapy or receive biologics as a first line therapy

Join this Trial

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Study Stats
Protocol No.
20-001072
Category
Gastroenterology
Contact
Melissa Arevalo
Location
  • UCLA Westwood
For Providers
NCT No.
NCT03952364
For detailed technical eligibility, visit ClinicalTrials.gov.