NCT07035691Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 582 (estimated)
- First submitted
- 11 Jun 2025
- Start date
- Jun 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Queen Mary University of London
- Diseases
- Colorectal cancer
- NCT number
- NCT07035691
What you commit to
- Study type: Observational
- Planned participants: 582
- From Jun 2025 to the primary completion date, Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Patients with untreated solid organ cancers.
- Patients with known inflammatory bowel disease.
Age
- Age \< 18 years.
Other
- 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 documented familial type CRC.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Barts Health NHS Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.