Crohn DiseaseNCT03952364
The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
An observational study of Crohn Disease and Ulcerative Colitis, run by PredictImmune Ltd at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, IBD
- What is being tested?
- PredictSURE IBD™
- How many people
- 200 participants
- Where
- 8 sitesUnited States
- Study dates
- 10 Oct 2019to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The target patient populations are newly diagnosed, active CD or UC in patients who are immunomodulator and anti-TNFα treatment naïve.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
ClinSearch
Chattanooga, Tennessee, 37421
Misti Earwood, 423-698-4584, mearwood@clinsearch-us.com
Mark McKenzie, MD
- Recruiting
University of Miami Crohn's and Colitis Center
Miami, Florida, 33136
Mills Grechen, 305-243-6405, gmills@med.miami.edu
Oriana Damas, MD
- Recruiting
Rutgers Robert Wood Johnson Medical School (Adult)
New Brunswick, New Jersey, 08901
Roohi Patel, MD, rp583@rwjms.rutgers.edu
Lea Ann Chen, MD
- Recruiting
Rutgers Robert Wood Johnson Medical School (Prediatric)
New Brunswick, New Jersey, 08901
Lisa Cerracchio, 732-235-5976, cerracli@rwjms.rutgers.edu
Melissa Weidner, MD
- Recruiting
Manhattan Clinical Research, LLC.
New York, New York, 10016
Resmi Varughese, 212-889-5544 ext. 9472, rvarughese@vanguardgi.com
Caterina Oneto, MD
- Recruiting
NYU Langone Health
New York, New York, 10016
Ghoncheh Ghiasian, 646-501-7822, ghoncheh.ghiasian@nyulangone.org
Jordan Axelrad, MD
- Recruiting
Weill Cornell Medical Center
New York, New York, 10065
Laura Cvetkovski, 646-697-0985 ext. 2220988, lac4009@med.cornell.edu
Dana Lukin, MD
- Recruiting
Washington University in St. Louis
St Louis, Missouri, 63130
Baylee Kinnett, kinnettb@wustl.edu
Deepak Parakkal, MD
About this study
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.
Read the 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.
- Conditions
- Crohn Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Diseases
- Being tested
- PredictSURE IBD™
- Keywords
- Crohn's Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Disease, Precious
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PredictSURE IBD™Other
To evaluate a test called PredictSURE IBD™ in the US population
What is being measured
The primary outcome is the main question the study is designed to answer.
To stratify patients at diagnosis into high and low- risk cohorts
Stratifying patients into high or low risk of following an aggressive disease course requiring frequent treatment escalations.
Measured: 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start10 Oct 2019
- Primary completionJun 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PredictImmune Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Crohn's and Colitis Foundation
- Responsible party
- Sponsor
- Investigators
- James Lee, MD, Principal investigator, PredictImmune Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952364
- Sponsor's protocol ID
- The Precious Study
- Status last verified
- Oct 2021
- First submitted
- 14 May 2019
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PRECIOUS Study: Predicting Crohn's & ColitIs Outcomes in the United States
- ClinicalTrials.gov ID
- NCT03952364
- Acronym / sponsor ID
- The Precious Study
- Conditions
- Crohn Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Diseases
- Keywords
- Crohn's Disease, Ulcerative Colitis, IBD, Inflammatory Bowel Disease, Precious
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- PredictImmune LtdIndustry (pharma, biotech, devices)
- Collaborators
- Crohn's and Colitis Foundation
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The target patient populations are newly diagnosed, active CD or UC in patients who are immunomodulator and anti-TNFα treatment naïve.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PredictSURE IBD™To evaluate a test called PredictSURE IBD™ in the US population | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Lee, MD principal investigator
PredictImmune Ltd
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease and Ulcerative Colitis, run by PredictImmune Ltd at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karen Hills, PhD (+44 (0) 1223 804195, khills@predictimmune.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To stratify patients at diagnosis into high and low- risk cohorts (time frame: 12 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.