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

October 12, 2021 updated by: PredictImmune Ltd
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 Overview

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Crohn's and Colitis Center
        • Contact:
        • Principal Investigator:
          • Oriana Damas, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University in St. Louis
        • Contact:
        • Principal Investigator:
          • Deepak Parakkal, MD
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School (Adult)
        • Principal Investigator:
          • Lea Ann Chen, MD
        • Contact:
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Robert Wood Johnson Medical School (Prediatric)
        • Contact:
        • Principal Investigator:
          • Melissa Weidner, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Principal Investigator:
          • Jordan Axelrad, MD
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical Center
        • Principal Investigator:
          • Dana Lukin, MD
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • Manhattan Clinical Research, LLC.
        • Principal Investigator:
          • Caterina Oneto, MD
        • Contact:
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • ClinSearch
        • Principal Investigator:
          • Mark McKenzie, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: James Lee, MD, PredictImmune Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 16, 2019

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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