New bioMarkers tO straTIfy cOlorectal caNcer Referrals
Recruiting · NCT07035691 · Observational (researchers observe without assigning treatment) · Lead sponsor: Queen Mary University of London
View the official record on ClinicalTrials.gov →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.
Who can take part
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 it is running
1 location listed.
- Barts Health NHS Trust - London, England, United Kingdom