PredictSURE-IBD™

Predicting long-term disease outcomes in IBD at the time of diagnosis
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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.
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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.
  • Aged 16-80 years old.

*Ideal patients for this study are newly diagnosed and treatment-naïve.

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Exclusion criteria

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
  • Hemoglobin
  • Albumin
  • Harvey Bradshaw Index (Crohn’s)
  • Modified Mayo score (UC)
  • Initial treatment
  • Date of treatment escalations and treatment received
  • Date of chart review

Study procedures & assessments

Newly diagnosed patients with CD and UC will be recruited from a predominantly outpatient setting. Potential study patients will be identified by local clinical team members and given a patient information leaflet (PIL).

Assessments and data collection will be performed by appropriately trained and qualified research staff, as delegated by the principal investigator at each site.

Blood sample collection for biomarker risk assessment

A  blood sample will be collected for the PredictSURE IBD™ test. The blood collection tubes and appropriate boxes will be provided with the necessary pre-addressed slips. Once collected, the sample is stable for up to 72 hours at room temperature.

Patient data collection/retrospective chart review

A spreadsheet or database will be provided to fill in the details about recruited patients, including a unique identifier. Data will be collected at the first visit (enrolment) with a retrospective patient chart review at end of study – up to 18 months after enrolment.

Data analysis

Previous studies have demonstrated the ability of PredictSURE IBD™ to stratify IBD patients into high- and low-risk of aggressive disease at the time of diagnosis. The aim of this study is to validate that PredictSURE IBD™ provides similar risk stratification in a US IBD population. As a consequence, data analysis will focus on looking for a correlation between risk category, as determined by the PredictSURE IBD™ test and clinical outcomes, as measured by the need for treatment escalation. 

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

What’s involved?

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.

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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.

PredictImmune

PredictImmune is a UK-based start-up company developing and commercialising pioneering tools for guiding personalised treatment options for inflammatory and autoimmune diseases, including vasculitis, Lupus (SLE) and inflammatory bowel disease (IBD).

The company’s first test for IBD was discovered and developed in the laboratory of Professor Kenneth Smith, Head of the Department of Medicine at the University of Cambridge, in collaboration with gastroenterologists at Cambridge University Hospitals NHS Foundation Trust and other UK NHS hospital trusts.

PredictSURE IBD™

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.

  1. Biasci, D. et al (2019) A blood-based prognostic biomarker in IBD.  http://dx.doi.org/10.1136/gutjnl-2019-318343
  2. Further publications

Recruitment

The PRECIOUS study is running at the following sites:

Study Sites
Northwell, Health Inc
PI: Dr Keith Sultan

Study Sites
University of Southern California
PI: Sarah Sheibani, MD

Study Sites
NYU Langone/Bellevue
PI: Dr Lea Ann Chen

Study Sites
Weill Cornell
PI: Dana Lukin

Study Sites
NYU Winthrop
PI: Raluca Vrabie, MD

Study Sites
WR-ClinSearch
PI: Dr Mark McKenzie

Study Sites
Columbia University
PI: Garrett Lawlor, MD

Study Sites
Washington University in St. Louis
PI: Dr Deepak Parakkal

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14 Patients recruited

Contact Us

General
Email PRECIOUS

T (UK) +44 (0) 1223 804 198

Principal
Dr James Lee, Wellcome Trust Intermediate Clinical Fellow and Consultant Gastroenterologist, University of Cambridge
Email James

Co-Principal
Lea Ann Chen, MD FACG, Assistant Prof of Medicine, NYU Langone Health
Email Lea Ann