Colorectal cancer Cancer
Conditions
Interventions
Block randomisation with the intervention arm having their Raman spectroscopy blood test done immediately and the control arm having their sample tested after they’ve had a diagnosis. Total follow up
Sponsors
Abertawe Bro Morgannwg University Health Board
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 50 years or over at time of presentation to GP symptoms/signs raising suspicion of CRC: 1.1. Rectal bleeding and change of bowel habit (looser stool/increased frequency persisting for 6 weeks 1.2. Rectal bleeding alone without anal symptoms or change in bowel habit persisting for 6 weeks 1.3. Change in bowel habit alone (looser stools/increased frequency) without rectal bleeding persisting for 6 weeks 1.4. Unexplained iron deficiency anaemia, haemoglobin of <110 g/l in men; OR unexplained iron deficiency anaemia, haemoglobin of <100 g/l in non-menstruating women 2. Able and willing to give informed consent to participate 3. Willing to provide a fasting blood sample 4. Willing to grant researchers access to identifiable data to enable result feedback to GP;Inclusion criteria: 1. Aged 50 years or over at time of presentation to GP symptoms/signs raising suspicion of CRC: 1.1. Rectal bleeding and change of bowel habit (looser stool/increased frequency persisting for 6 weeks 1.2. Rectal bleeding alone without anal symptoms or change in bowel habit persisting for 6 weeks 1.3. Change in bowel habit alone (looser stools/increased frequency) without rectal bleeding persisting for 6 weeks 1.4. Unexplained iron deficiency anaemia, haemoglobin of <110 g/l in men; OR unexplained iron deficiency anaemia, haemoglobin of <100 g/l in non-menstruating women 2. Able and willing to give informed consent to participate 3. Willing to provide a fasting blood sample 4. Willing to grant researchers access to identifiable data to enable result feedback to GP
Exclusion criteria
Exclusion criteria: 1. Patients in whom a secondary care referral is considered mandatory in the opinion of the GP (e.g. clinically detected rectal or abdominal mass) 2. Patients with a prior history of CRC or other invasive malignancy within the last 5 years 3. Patients with signs/symptoms which require emergency referral to secondary care or A&E (e.g. intestinal obstruction, peritonitis, massive haemorrhage) 4. Patients with genetic conditions associated with CRC (Lynch syndrome and familial adenomatous polyposis) 5. Patients with known inflammatory bowel disease 6. Patient from vulnerable groups;Exclusion criteria: 1. Patients in whom a secondary care referral is considered mandatory in the opinion of the GP (e.g. clinically detected rectal or abdominal mass) 2. Patients with a prior history of CRC or other invasive malignancy within the last 5 years 3. Patients with signs/symptoms which require emergency referral to secondary care or A&E (e.g. intestinal obstruction, peritonitis, massive haemorrhage) 4. Patients with genetic conditions associated with CRC (Lynch syndrome and familial adenomatous polyposis) 5. Patients with known inflammatory bowel disease 6. Patient from vulnerable groups
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of recruited patients who are referred on the USC pathway within the intervention group and compared to the control group at 12 months;The proportion of recruited patients who are referred on the USC pathway within the intervention group and compared to the control group at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. USC pathway timelines in each group at 12 months: 1.1. Time from first GP appointment to date of referral (days) 1.2. Time from first GP appointment to first appointment in secondary care (days) 1.3. Time from first GP appointment to investigation (CT scan or colonoscopy) (days) 1.4. Time from first GP appointment to final diagnosis (days) 2. Number of patients referred on USC pathway pre/post phase 2 by participating practice at 12 months 3. Number of days on the USC/non-USC pathways pre/post phase 2 by participating practice at 12 months 4. Compliance with USC/non-USC pathway timeframes (62 or 31 days respectively) at 12 months by comparing the referral letter with the guidelines 5. Investigation result (cancer/non-cancer) at 12 months based on the final diagnosis in secondary care/GP records if the patient isn’t referred to secondary care 6. Estimate of the false negative rate for Raman test at 12 months based on the patient’s diagnosis vs the Raman test result (both arms) 7. Colorectal cancer stage (TNM system) by arm at 12 months if diagnosed with CRC 8. Ability to recruit GP practices to the feasibility trial at baseline – the trialists are aiming for 10 sites currently involved in a cohort study to continue into the RCT 9. Ability to recruit and retain participants into each arm of the feasibility trial at 12 months based on withdrawals, loss to follow up, questionnaire completion 10. Ability to collect patient QoL data at all three time points to be assessed per patient as their journey progresses. The final QoL questionnaire is done when they have a diagnosis which will vary significantly for patients 11. Thematic analysis of the responses to patient and doctor questionnaires and interviews at 2 months post-diagnosis per consenting patient;1. USC pathway timelines in each group at 12 months: 1.1. Time from first GP appointment to date of referral (days) 1.2. Time from first GP appointment to first appointment in secondary care (days) 1.3. Time from first | — |
Countries
United Kingdom
Contacts
Public ContactKym;Kym Thorne;Thorne
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Outcome results
None listed