The PRECIOUS Study:
Predicting Crohn’s & Colitis Outcomes in the United States
PRECIOUS is an observational study investigating the ability of a prognostic biomarker to predict long-term outcomes in inflammatory bowel disease (IBD) in the US.
It utilises the PredictSURE IBD™ biomarker to stratify patients at diagnosis into high-risk and low-risk cohorts, based on their risk of subsequently experiencing a severe disease course, characterised by the requirement for multiple escalations in treatment due to frequently relapsing or chronically active disease. The biomarker was developed by researchers at Professor Ken Smith’s laboratory, at the University of Cambridge (UK); its discovery and validation has been presented at key conferences (including the Crohn’s & Colitis Congress) and published in a number of prestigious peer-reviewed journals.
About the study
- Study design: A multi-center, observational study of patients with active Crohn’s disease (CD) or ulcerative colitis (UC), who are not receiving systemic steroids, immunomodulators or biologics. The study will recruit up to 200 patients from centers across the US.
- Study aim: Assess whether a prognostic biomarker can stratify IBD patients in the US according to their subsequent disease course.
- Study duration: Recruitment will continue for 12 months, with follow up of up to 18 months following initial blood sample collection.
- Treatment algorithm: Patients will be treated using a step-up or accelerated step-up strategy in line with local practice.
- 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.
- Aged 16-80 years old.
*Ideal patients for this study are newly diagnosed and treatment-naïve.
The presence of any of the following will preclude patient inclusion:
- 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
Clinical data to be recorded
- Unique patient ID
- Study entry date
- Gender, race & date of birth
- Smoking status
- Disease location & behaviour
- Perianal involvement (Crohn’s)
- Faecal calprotectin
- Harvey Bradshaw Index (Crohn’s)
- Modified Mayo score (UC)
- Initial treatment
- Date of treatment escalations and treatment received
- Date of chart review
Information for Patients
If you are between the ages of 16-80 and suffer from Crohn’s disease or ulcerative colitis (UC), you may be eligible to participate in this research study.
Who can participate?
- The target patient population is newly diagnosed, treatment-naïve patients with active Crohn’s disease or UC
- Not currently on steroids, and at least 7 days since last steroid use
- Experiencing a flare or period of active disease
- Not scheduled to start biologics as first line therapy
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. The study will run for up to 12 months. The only difference to your medical care is that as part of the study, you will be asked to provide one extra 2.5 ml (approximately half a teaspoon) blood sample at the beginning of the 12-month period.
What are the benefits?
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. We will reimburse any reasonable travel and parking costs up to a value of $50.
Crohn’s and Colitis Foundation
The Crohn’s & Colitis Foundation is a US-based, non-profit, volunteer-driven organization dedicated to finding cures for Crohn’s disease and ulcerative colitis, and to improving the quality of life of children and adults affected by these diseases.
The foundation collaborates with healthcare providers to improve IBD quality of care, as well as educating, supporting, and empowering patients and their care givers through patient-centric education and advocacy programs.
PredictSURE IBD™ is a simple, blood-based prognostic test for inflammatory bowel disease (IBD), that works in both Crohn’s disease (CD) and ulcerative colitis (UC). The test is carried out at the point when you have a clear diagnosis of CD or UC, and accurately identifies which patients are at risk of experiencing severe, relapsing disease. These patients are likely to benefit from early biologics therapy.
The test is a result of over 10 years of world-leading research at University of Cambridge, UK, and was validated in an independent cohort of 123 IBD patients recruited from 4 UK centres¹. This study seeks to extend this validation to a US population.
The PRECIOUS study is running at the following sites:
Northwell, Health Inc
PI: Dr Keith Sultan
University of Southern California
PI: Sarah Sheibani, MD
Rutgers Robert Wood Johnson Medical School
PI: Dr Melissa Weidner
PI: Dr Lea Ann Chen
PI: Dana Lukin
PI: Raluca Vrabie, MD
University of Rochester, Medical Center
PI: Dr. Saubermann
PI: Dr Mark McKenzie
PI: Garrett Lawlor, MD
Washington University in St. Louis
PI: Dr Deepak Parakkal
Manhattan Clinical Research, LLC.
233 Broadway, Suite 2750, New York, NY 10279.
PI: Dr Caterina Oneto