NCT07035691 New bioMarkers tO straTIfy cOlorectal caNcer Referrals
| NCT ID | NCT07035691 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Mary University of London |
| Condition | Colorectal Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 582 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 582 participants in total. It began in 2025-06-30 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Mohamed A Thaha, MBBS, FRCS, PhD, PGCe Hlt Econ
PRINCIPAL INVESTIGATOR
Queen Mary University of London
Frequently Asked Questions
Who can join the NCT07035691 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07035691 currently recruiting?
Yes, NCT07035691 is actively recruiting participants. Contact the research team at v.butnari@qmul.ac.uk for enrollment information.
Where is the NCT07035691 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT07035691 clinical trial?
NCT07035691 is sponsored by Queen Mary University of London. The principal investigator is Mohamed A Thaha, MBBS, FRCS, PhD, PGCe Hlt Econ at Queen Mary University of London. The trial plans to enroll 582 participants.