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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 : July 19, 2019
Sponsor:
Collaborator:
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.

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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
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

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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

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, New York
NYU Langone Health/Bellevue Recruiting
New York, New York, United States, 10016
Contact: Lily Deng    212-263-4163    lily.deng@nyulangone.org   
Principal Investigator: Lea Ann Chen, MD         
Sponsors and Collaborators
PredictImmune Ltd
The Crohn's and Colitis Foundation
Investigators
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Principal Investigator: James Lee, MD PredictImmune Ltd

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Responsible Party: PredictImmune Ltd
ClinicalTrials.gov 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

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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