The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
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| ClinicalTrials.gov Identifier: NCT03952364 |
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Recruitment Status :
Recruiting
First Posted : May 16, 2019
Last Update Posted : October 14, 2021
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Sponsor:
PredictImmune Ltd
Collaborator:
Crohn's and Colitis Foundation
Information provided by (Responsible Party):
PredictImmune Ltd
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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™ |
| 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 |
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 :
- 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
| Contact: Karen Hills, PhD | +44 (0) 1223 804195 | khills@predictimmune.com |
Locations
| 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
Crohn's and Colitis Foundation
Investigators
| 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 |
Keywords provided by PredictImmune Ltd:
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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 |