NCT03952364

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: PredictImmune Ltd · Industry
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multi-center, observational study of newly diagnosed IBD (CD or UC) patients. The Study aims to assess whether a prognostic biomarker can stratify IBD patients in the US.

Conditions

• Crohn Disease
• Ulcerative Colitis
• IBD
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
OTHER	PredictSURE IBD™	To evaluate a test called PredictSURE IBD™ in the US population

Timeline

• Start date: 2019-10-10
• Primary completion: 2022-06-01
• Completion: 2022-06-01
• First posted: 2019-05-16
• Last updated: 2021-10-14

Locations

8 sites across 1 country: United States