RecruitingNCT07035691

New bioMarkers tO straTIfy cOlorectal caNcer Referrals

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


Sponsor

Queen Mary University of London

Enrollment

582 participants

Start Date

Jun 30, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether new blood biomarkers (biological indicators in the blood) can help doctors more accurately sort people referred urgently for lower bowel cancer investigations — helping prioritize those most likely to have cancer while reducing unnecessary procedures for those who don't. **You may be eligible if...** - You are an adult (over 18 years old) - You have been referred urgently (through a "2-week wait" or Straight to Test pathway) for suspected lower bowel (colorectal) cancer - You do not have a history of inflammatory bowel disease (for 2WW referrals) - Your fitness level (ECOG 0–2, or 3 pending assessment) allows you to participate - You have capacity to consent **You may NOT be eligible if...** - You were referred outside the urgent 2WW or Straight to Test pathways - You were referred as an emergency - You are under 18 - You are not fit enough for standard colorectal investigations Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Barts Health NHS Trust

London, England, United Kingdom

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NCT07035691


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