The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
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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. |
ClinicalTrials.gov Identifier: NCT03952364 |
Recruitment Status :
Recruiting
First Posted : May 16, 2019
Last Update Posted : October 14, 2021
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Condition or disease | Intervention/treatment |
---|---|
Crohn Disease Ulcerative Colitis IBD Inflammatory Bowel Diseases | Other: PredictSURE IBD™ |
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 2022 |
Estimated Study Completion Date : | June 2022 |

- Other: PredictSURE IBD™
To evaluate a test called PredictSURE IBD™ in the US population
- 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

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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 |
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

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
Contact: Karen Hills, PhD | +44 (0) 1223 804195 | khills@predictimmune.com |
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 |
Principal Investigator: | James Lee, MD | PredictImmune Ltd |
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: | October 14, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Crohn's Disease Ulcerative Colitis IBD Inflammatory Bowel Disease Precious |
Crohn Disease Colitis Colitis, Ulcerative Intestinal Diseases Inflammatory Bowel Diseases Ulcer |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes |