- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03952364
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
Status
Recruiting
Intervention / Treatment
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
- Name: Karen Hills, PhD
- Phone Number: +44 (0) 1223 804195
- Email: khills@predictimmune.com
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami Crohn's and Colitis Center
-
Contact:
- Mills Grechen
- Phone Number: 305-243-6405
- Email: gmills@med.miami.edu
-
Principal Investigator:
- Oriana Damas, MD
-
-
Missouri
-
Saint Louis, Missouri, United States, 63130
- Recruiting
- Washington University in St. Louis
-
Contact:
- Baylee Kinnett
- Email: kinnettb@wustl.edu
-
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:
- Roohi Patel, MD
- Email: rp583@rwjms.rutgers.edu
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Rutgers Robert Wood Johnson Medical School (Prediatric)
-
Contact:
- Lisa Cerracchio
- Phone Number: 732-235-5976
- Email: cerracli@rwjms.rutgers.edu
-
Principal Investigator:
- Melissa Weidner, MD
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
Principal Investigator:
- Jordan Axelrad, MD
-
Contact:
- Ghoncheh Ghiasian
- Phone Number: 646-501-7822
- Email: Ghoncheh.Ghiasian@nyulangone.org
-
New York, New York, United States, 10065
- Recruiting
- Weill Cornell Medical Center
-
Principal Investigator:
- Dana Lukin, MD
-
Contact:
- Laura Cvetkovski
- Phone Number: 2220988 646-697-0985
- Email: lac4009@med.cornell.edu
-
New York, New York, United States, 10016
- Recruiting
- Manhattan Clinical Research, LLC.
-
Principal Investigator:
- Caterina Oneto, MD
-
Contact:
- Resmi Varughese
- Phone Number: 9472 212-889-5544
- Email: rvarughese@vanguardgi.com
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37421
- Recruiting
- ClinSearch
-
Principal Investigator:
- Mark McKenzie, MD
-
Contact:
- Misti Earwood
- Phone Number: 423-698-4584
- Email: mearwood@clinsearch-us.com
-
-
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- The Precious 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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