New bioMarkers tO straTIfy cOlorectal caNcer Referrals
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQueen Mary University of London
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial population
All adult patients who are referred by the GPs to the Barts Health NHS trust under the 2WW referral pathway and the STT pathway would be potentially eligible. We are planning to recruit patients initially only from the Royal London Hospital site and there is potential to expand recruitment to other hospital sites of Barts Health NHS Trust, if necessary.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
582 Participants
are grouped into 1 trial groupGroup A: Patients with flag symptoms referred via 2 week wait pathway to exclude colorectal cancer.
Trial outcomes
Primary outcomes
1
Predictive value of hPG80 to identify colorectal cancer and adenomatous polyp
Sensitivity and Specificity of hPG80 to determine colorectal cancer and adenomatous polyp
Time frame
From enrollment to 8 weeks (or until the 2WW diagnostic test is completed and the outcome available).2
Identification of Transposable Element (TE) signatures in plasma of colorectal cancer patients
Expression of transposable element (TE) signatures in the plasma of patients with colorectal cancer and adenomatous polyps compared to healthy controls.
Time frame
From enrollment to 8 weeks (or until the 2WW diagnostic test is completed and the outcome available).Other outcomes
1
Patient preference and choice of diagnostic tests for colorectal cancer
Survey based assessment of patient preferences and choices of different tests used in the colorectal 2WW pathway.
Time frame
12 weeks post recruitment dateSponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen Mary University of London
Lead sponsor
Barts & The London NHS Trust
Collaborator
Source ClinicalTrials.gov