Blood markers to better sort who needs urgent colorectal testing
Plasma Biomarkers in Stratifying Patients Referred Via the Lower Gastro-intestinal (LGI) Suspected Cancer Two-week Wait (2WW) Pathway
This will test whether a blood test measuring hPG80 and mobile genetic elements can spot colorectal cancer or polyps in adults referred for urgent bowel investigations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 582 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 1 site (London, England) |
| Trial ID | NCT07035691 on ClinicalTrials.gov |
What this trial studies
This observational project will collect a 20 ml blood sample from adults referred to the two‑week‑wait (2WW) or Straight to Test (STT) pathway for suspected lower gastrointestinal cancer. Plasma will be analyzed for circulating progastrin (hPG80) levels and signatures of transposable elements (TEs), and results will be compared with findings from routine diagnostic investigations such as colonoscopy, CT colonography, and FIT. Participants will receive standard clinical care and their final clinical diagnosis will serve as the reference standard for biomarker performance. The project will also record patient preferences for a blood-based test versus more invasive diagnostic methods to inform acceptability and potential implementation.
Who should consider this trial
Good fit: Adults over 18 referred to the 2WW or STT pathway for suspected lower GI cancer who can give consent, are fit for standard investigations, and do not have inflammatory bowel disease or documented familial colorectal cancer.
Not a fit: Patients referred outside the 2WW/STT pathways (including emergency referrals), those with untreated solid organ cancers, known inflammatory bowel disease, or familial CRC are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, the blood test could reduce unnecessary invasive procedures and help prioritize patients who most need urgent colonoscopy.
How similar studies have performed: Prior work has reported higher hPG80 and altered TE signals in colorectal cancer and some polyps, but combining these markers and applying them prospectively in the 2WW/STT referral population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult, lower GI 2WW and or Straight to Test (STT) referral patients with suspected lower GI cancer. * Male and Female patients aged \>18 years. * 2WW referral patients with no history of inflammatory bowel disease. * Performance status (ECOG 0-2; and 3 pending clinical assessment of fitness). * Patients with capacity to consent to the study. Exclusion Criteria: * Any patients referred outside of the 2WW and or STT referral pathways with suspected Lower GI cancer or those referred as an emergency with or suspected CRC. * Age \< 18 years. * Patients not fit for standard investigations (e.g. not fit for gastroscopy, colonoscopy or CT colonography) in the 2WW pathway. * Patients with no capacity to consent or who declined consent for participation. * Patients with untreated solid organ cancers. * Patients with known inflammatory bowel disease. * Patients with documented familial type CRC.
Where this trial is running
London, England
- Barts Health NHS Trust — London, England, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Mohamed A Thaha, MBBS, FRCS, PhD, PGCe Hlt Econ — Queen Mary University of London
- Study coordinator: Valentin Butnari, MBBS, MSc
- Email: v.butnari@qmul.ac.uk
- Phone: +442078828747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.