Plasma Biomarkers in Stratifying Patients Referred Via the Lower Gastro-intestinal (LGI) Suspected Cancer Two-week Wait (2WW) Pathway

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Barts Health NHS Trust
RECRUITING
London
Contact Information
Primary
Valentin Butnari, MBBS, MSc
v.butnari@qmul.ac.uk
+442078828747
Backup
Eleanor McAlees
e.mcalees@qmul.ac.uk
+44 02078828747
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 582
Treatments
Patients with flag symptoms referred via 2 week wait pathway to exclude colorectal cancer.
An additional blood sample for the study.
Related Therapeutic Areas
Sponsors
Leads: Queen Mary University of London
Collaborators: Barts & The London NHS Trust

This content was sourced from clinicaltrials.gov