Actively Recruiting
New bioMarkers tO straTIfy cOlorectal caNcer Referrals
Led by Queen Mary University of London · Updated on 2025-08-08
582
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
Sponsors
Q
Queen Mary University of London
Lead Sponsor
B
Barts & The London NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this observational study is to evaluate if a blood test for circulating progastrin (hPG80) and transposable elements (TEs) can accurately predict colorectal cancer (CRC) or polyps in adult patients referred to the 2-week wait (2WW) or Straight to Test (STT) pathways for suspected lower gastrointestinal cancer. The main questions it aims to answer are: Can plasma hPG80 levels accurately predict a diagnosis of CRC or polyps in patients undergoing standard 2WW investigations? Can transposable elements (TEs) in the plasma serve as predictive biomarkers for CRC diagnosis in these patients? What are the patient preferences for different diagnostic tests for CRC, particularly a blood-based test compared to more invasive methods? Participants will: Provide a 20ml blood sample during a routine hospital visit for their 2WW diagnostic test (e.g., colonoscopy, CT Colon). Undergo standard clinical investigations as determined by their treating clinicians. Have their final diagnosis (cancer, polyp, or normal) correlated with their plasma hPG80 levels. For a subset of 100 participants (25 with confirmed CRC, 75 non-cancer), have their plasma analyzed for circulating signatures using RNAseq and DNAseq. Complete an electronic post-study questionnaire to explore their preferences and experiences with different CRC diagnostic tests used within the 2WW pathway.
CONDITIONS
Official Title
New bioMarkers tO straTIfy cOlorectal caNcer Referrals
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients referred via the 2WW or Straight to Test pathway for suspected lower GI cancer
- Male and female patients aged over 18 years
- Patients with no history of inflammatory bowel disease
- Performance status of ECOG 0-2 or 3 pending clinical assessment
- Patients able to provide informed consent
You will not qualify if you...
- Patients referred outside the 2WW or Straight to Test pathways or as an emergency with suspected CRC
- Patients under 18 years old
- Patients unfit for standard investigations like colonoscopy or CT colonography
- Patients unable or unwilling to provide consent
- Patients with untreated solid organ cancers
- Patients with known inflammatory bowel disease
- Patients with documented familial type colorectal cancer
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Barts Health NHS Trust
London, England, United Kingdom, E1 2AT
Actively Recruiting
Research Team
V
Valentin Butnari, MBBS, MSc
CONTACT
E
Eleanor McAlees
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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