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

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ClinicalTrials.gov Identifier: NCT03952364
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : March 19, 2021
Sponsor:
Collaborator:
The Crohn's and Colitis Foundation
Information provided by (Responsible Party):
PredictImmune Ltd

Study Description
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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.
Study Design
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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
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


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

Outcome Measures
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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.

Eligibility Criteria
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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.
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03952364


Contacts
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Contact: Karen Hills, PhD +44 (0) 1223 804195 khills@predictimmune.com

Locations
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United States, Florida
University of Miami Crohn's and Colitis Center Recruiting
Miami, Florida, United States, 33136
Contact: Mills Grechen    305-243-6405    gmills@med.miami.edu   
Principal Investigator: Oriana Damas, MD         
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Baylee Kinnett       kinnettb@wustl.edu   
Principal Investigator: Deepak Parakkal, MD         
United States, New Jersey
Rutgers Robert Wood Johnson Medical School (Adult) Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Roohi Patel, MD       rp583@rwjms.rutgers.edu   
Principal Investigator: Lea Ann Chen, MD         
Rutgers Robert Wood Johnson Medical School (Prediatric) Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Lisa Cerracchio    732-235-5976    cerracli@rwjms.rutgers.edu   
Principal Investigator: Melissa Weidner, MD         
United States, New York
Manhattan Clinical Research, LLC. Recruiting
New York, New York, United States, 10016
Contact: Resmi Varughese    212-889-5544 ext 9472    rvarughese@vanguardgi.com   
Principal Investigator: Caterina Oneto, MD         
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Ghoncheh Ghiasian    646-501-7822    ghoncheh.ghiasian@nyulangone.org   
Principal Investigator: Jordan Axelrad, MD         
Weill Cornell Medical Center Recruiting
New York, New York, United States, 10065
Contact: Laura Cvetkovski    646-697-0985 ext 2220988    lac4009@med.cornell.edu   
Principal Investigator: Dana Lukin, MD         
United States, Tennessee
ClinSearch Recruiting
Chattanooga, Tennessee, United States, 37421
Contact: Misti Earwood    423-698-4584    mearwood@clinsearch-us.com   
Principal Investigator: Mark McKenzie, MD         
Sponsors and Collaborators
PredictImmune Ltd
The Crohn's and Colitis Foundation
Investigators
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Principal Investigator: James Lee, MD PredictImmune Ltd
More Information
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Responsible Party: PredictImmune Ltd
ClinicalTrials.gov Identifier: NCT03952364    
Other Study ID Numbers: The Precious Study
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
IBD
Inflammatory Bowel Disease
Precious
Additional relevant MeSH terms:
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Crohn Disease
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
 Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes