The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
NCT ID: NCT03952364
Last Updated: 2021-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2019-10-10
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PredictSURE IBD™
To evaluate a test called PredictSURE IBD™ in the US population
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
16 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Crohn's and Colitis Foundation
OTHER
PredictImmune Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
James Lee, MD
Role: PRINCIPAL_INVESTIGATOR
PredictImmune Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami Crohn's and Colitis Center
Miami, Florida, United States
Washington University in St. Louis
St Louis, Missouri, United States
Rutgers Robert Wood Johnson Medical School (Adult)
New Brunswick, New Jersey, United States
Rutgers Robert Wood Johnson Medical School (Prediatric)
New Brunswick, New Jersey, United States
Manhattan Clinical Research, LLC.
New York, New York, United States
NYU Langone Health
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
ClinSearch
Chattanooga, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
The Precious Study
Identifier Type: -
Identifier Source: org_study_id