Figure 2: How we envisage the PredictSURE IBD test being used to help identify the best treatment course for individual patients based on their likely disease course.
Why is the PRECIOUS study important?
PredictSURE IBD was originally shown to reliably identify high- and low-risk IBD patients at 4 UK sites. This patient group was ~90% Caucasian, so we were keen to ensure that the test is effective in a more diverse patient population. We chose North America for its diversity and also because we wanted to give US and Canadian clinicians a chance to become familiar with the test to support its uptake when it is approved for clinical use in the United States.
We successfully applied to the Crohn’s & Colitis Foundation for support to fund the study and are grateful to the Foundation for their ongoing support.
How is the study going?
The PRECIOUS study started recruitment in early 2019 under the guidance of our two Chief Investigators: Dr James Lee and Dr Lea Ann Chen. PRECIOUS is recruiting at 15 sites:
- Northwell, Health Inc, PI: Dr Keith Sultan
- University of Southern California, PI: Sarah Sheibani, MD
- Rutgers Robert Wood Johnson Medical School (pediatric), PI: Dr Melissa Weidner
- Rutgers Robert Wood Johnson Medical School (Adult), PI: Dr Lea Ann Chen
- John Hopkins Medical Center (pediatric), PI: Maria Oliva-Hemker, MD
- NYU Langone/Bellevue, PI: Dr Jordan Axelrad MD
- Weill Cornell, PI: Dana Lukin
- NYU Winthrop, PI: Bradley Morgenstern, MD
- University of Rochester, Medical Center, PI: Dr. Saubermann
- University of Miami Crohn’s and Colitis Center, PI: Oriana Damas, MD
- UCLA Center for IBD, PI: Jenny Sauk, MD
- Mount Sinai Hospital (Toronto), PI: Ken Croitoru, MD
- Washington University in St. Louis, PI: Dr Deepak Parakkal
- Manhattan Clinical Research, LLC., PI: Dr Caterina Oneto
- Johns Hopkins IBD Center for Adults, PI: Brindusa Truta, MD
Who can participate?
We are seeking patients with a new or recent diagnosis of Crohn’s disease or ulcerative colitis who are biologic-naïve and who have active disease.
- Patients cannot be on steroids at the time of blood draw and must be steroid free for at least 7 days prior to blood draw
- Patients must be experiencing a flare or period of active disease
- Patient cannot be scheduled to start biologics as first line therapy
Despite the Covid pandemic and its impact on all studies, we are proud to have recruited 126 patients and are grateful for the hard work and dedication of our study teams and our intrepid study recruits.
Recruitment will continue until the end of March 2023, so if you or someone you know has a recent IBD diagnosis and is being treated at one of our sites, please check out the PRECIOUS website to find out more.
You can also contact Karen Hills or Lediona Ardolli for more information.