The PRECIOUS Study: Predicting Crohn’s & Colitis Outcomes in the United States
Published: 11/23/2022
General Information:
To demonstrate that PredictSURE IBD can stratify an ethnically diverse North American population into high and low risk based on the need for early and frequent treatment escalations in the high-risk cohort.
Eligibility:
Inclusion criteria:
- Aged 16-80 years old
- 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
Exclusion criteria:
- Patients with fistulating perianal 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 Details:
Study description/explanation of participation:
The PRECIOUS study is testing the ability of a blood test called “PredictSURE IBD” to determine whether your disease will follow a mild or aggressive course. The test has already been demonstrated to work well in a UK population, so the PRECIOUS study aims to confirm this result in a different group of patients.
Involvement in this study does not require any additional visits to your gastroenterologist, primary care physician or any additional treatments that would not otherwise be needed but does require an additional 2.5 ml (half a teaspoon) blood sample at the beginning of the study, which will run for up to 12 months in the first instance.
If the study is successful, it will provide further evidence for the use of the test to drive treatment decisions in IBD and will be the first step towards personalized medicine in the US.
Description of treatment or intervention (mechanism of action):
No treatment intervention - this is an observational study
Participation requirements:
As part of the study the patient will be asked to provide up to 3 (2.5 ml) blood samples for biomarker analysis. The study is observational and as such doesn’t require additional clinic visits or any change in their planned treatment course.
Initial follow up is for 12 months, but patients can also elect to consent to longer follow-up for a total of 3 years. We will reimburse any reasonable travel and parking costs up to a value of $50.
Possible risks and side effects:
Possible adverse reaction when taking blood draw.
The Foundation is not involved in the study and cannot be held responsible for anything which may occur in connection with the study; however, the Foundation is a funder of the underlying proprietary tool involved in this study.