Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03952364
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : July 19, 2019
The Crohn's and Colitis Foundation
Information provided by (Responsible Party):
PredictImmune Ltd

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.

Condition or disease Intervention/treatment
Crohn Disease Ulcerative Colitis IBD Inflammatory Bowel Diseases Other: PredictSURE IBD™

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: PredictSURE IBD™
    To evaluate a test called PredictSURE IBD™ in the US population

Primary Outcome Measures :
  1. To stratify patients at diagnosis into high and low- risk cohorts [ Time Frame: 12 month follow up ]
    Stratifying patients into high or low risk of following an aggressive disease course requiring frequent treatment escalations.

Biospecimen Retention:   Samples With DNA
Following patient consent and recruitment to the study, a 2.5 ml blood sample will be collected in a PAXgene tube.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The target patient populations are newly diagnosed, active CD or UC in patients who are immunomodulator and anti-TNFα treatment naïve.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03952364

Layout table for location contacts
Contact: Karen Hills, PhD +44 (0) 1223 804195

Layout table for location information
United States, New York
NYU Langone Health/Bellevue Recruiting
New York, New York, United States, 10016
Contact: Lily Deng    212-263-4163   
Principal Investigator: Lea Ann Chen, MD         
Sponsors and Collaborators
PredictImmune Ltd
The Crohn's and Colitis Foundation
Layout table for investigator information
Principal Investigator: James Lee, MD PredictImmune Ltd

Layout table for additonal information
Responsible Party: PredictImmune Ltd Identifier: NCT03952364     History of Changes
Other Study ID Numbers: The Precious Study
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by PredictImmune Ltd:
Crohn's Disease
Ulcerative Colitis
Inflammatory Bowel Disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes