Evaluation of a novel bowel cancer blood test to prioritise the colonoscopy waiting list
| ISRCTN | ISRCTN92139363 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92139363 |
| Integrated Research Application System (IRAS) | 328257 |
| Sponsor | Swansea Bay University Health Board |
| Funder | Moondance Cancer Initiative |
- Submission date
- 12/01/2026
- Registration date
- 20/05/2026
- Last edited
- 20/05/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Further colonoscopy tests are usually required after treatment for bowel cancer or after removal of bowel polyps to detect if the cancer or polyp has returned. Many of these colonoscopies are now overdue after they were paused by the COVID-19 pandemic. At present there is no reliable way to tell if a polyp or bowel cancer recurrence is present, aside from performing the colonoscopy. Delays to appointments increase patient anxiety and worry. A technique called Raman spectroscopy analysis of blood serum has shown good levels of accuracy for detecting colorectal cancer and polyps in work to date. The aim of this study is to assess the test performance of a Raman spectroscopy analysis for routine use in a real-world setting.
Who can participate?
Male and female participants aged 18 years and over who are overdue for a colonoscopy or sigmoidoscopy as part of their polyp or bowel cancer follow up
What does the study involve?
This study will recruit participants awaiting a follow-up colonoscopy following bowel cancer or polyp removal from a single university health board. The study will invite participants to have the blood test performed and they will be told the result. This will be compared with a software model created from blood samples from previously recruited patients where the outcome of their colonoscopy was known. Patients having blood test results indicating a high likelihood of a polyp or cancer being present will have the colonoscopy performed with the greatest urgency. Those with a low likelihood of polyp or cancer will have a lower priority appointment. The study will tell us how accurate the blood test is at prioritising colonoscopy so that in future, those at greatest risk of a recurrence of the cancer or polyp will be given priority for a colonoscopy
What are the possible benefits and risks of participating?
The study will improve our understanding of the best way to manage future participants who need colonoscopy procedures scheduled. There are small risks involved with taking a blood sample. These include bruising, bleeding, pain/discomfort, fainting or infection at the local site from which the blood is taken.
Where is the study run from?
Swansea Bay University Health Board (UK)
When is the study starting and how long is it expected to run for?
December 2023 to June 2025
Who is funding the study?
Moondance Cancer Initiative (UK)
Who is the main contact?
Prof. Dean Harris, dean.a.harris@wales.nhs.uk
Contact information
Principal investigator, Scientific, Public
Swansea Bay University Health Board
Swansea
SA2 8PP
United Kingdom
| Phone | +44 (0)1792 205666 |
|---|---|
| rhodri.stacey@wales.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Blinded (masking used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Diagnostic |
| Scientific title | Phase II prospective interventional multi-site performance evaluation trial of serum Raman spectroscopy and supervised machine learning classification in a colonoscopy surveillance population |
| Study objectives | |
| Ethics approval(s) |
Approved 18/10/2023, Yorkshire and the Humber (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Tyne and Wear, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8388; sheffield.rec@hra.nhs.uk), ref: 23/YH/0186 |
| Health condition(s) or problem(s) studied | Colorectal cancer, high risk polyp and genetic colorectal cancer predispositions |
| Intervention | Patients on the surveillance colonoscopy waiting list will be invited to provide a blood sample that will be analysed by Raman spectroscopy to determine a risk score for colorectal cancer and/or advanced adenomas. The colonoscopy findings will be compared to the blood test output to determine the test performance (sensitivity, specificity). |
| Intervention type | Device |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Raman spectroscopy |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 27/06/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Total final enrolment | 212 |
| Key inclusion criteria | 1. Male or female patients aged over 18 years 2. Overdue colonoscopy surveillance after previous adenoma/colorectal cancer diagnosis 3. Willing to provide evidence of written informed participation 4. Willing to attend for colonoscopy |
| Key exclusion criteria | 1. History of invasive or haematological malignancy diagnosed within the last 3 years 2. Unwilling to participate 3. Declines colonoscopy 4. Inflammatory bowel disease surveillance |
| Date of first enrolment | 07/12/2023 |
| Date of final enrolment | 27/06/2024 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Baglan Energy Park
Port Talbot
SA12 7BR
Wales
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
20/01/2026: Study's existence confirmed by the Yorkshire & The Humber - Sheffield Research Ethics Committee.
