Assessment of the impact on chemotherapy decision-making and cost effectiveness of the integration of the digital biomarker test OncoProg into early stage colon cancer treatment pathways
| ISRCTN | ISRCTN71056359 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71056359 |
| IRAS number | 330060 |
- Submission date
- 28/08/2024
- Registration date
- 11/09/2024
- Last edited
- 11/09/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Every year, about 42,000 people in the UK are diagnosed with bowel cancer, and around half of these cases are classified as early-stage (stage II and IIIA or IIIB (T1-3N1). Deciding whether these early-stage patients should receive chemotherapy is difficult because only a small number of them actually benefit from it. Currently, about half of these patients receive chemotherapy, but it only slightly improves survival rates and can have harmful side effects, especially for those who don’t need it.
Oxford Cancer Biomarkers Limited (OCB) has developed a new technology called OncoProg, which uses machine learning and image analysis to identify early-stage colon cancer patients who are likely to benefit from chemotherapy and those who are not. This study aims to integrate OncoProg into hospital routines to help doctors and patients make better decisions about chemotherapy after surgery, potentially improving the overall efficiency of the NHS.
Who can participate?
This study involves collecting data from patients with early-stage colon cancer who are undergoing routine pathology analysis at University Hospital Birmingham and its satellite sites in the West Midlands. You may be asked to participate if your tumour sample is being analysed as part of this routine care.
What does the study involve?
If you are part of this study, your tumour sample will be analysed using the OncoProg system as part of your routine care. The results from OncoProg will provide your doctors with additional information about your cancer to help decide whether chemotherapy is the right option for you. You won’t need to do anything extra beyond your normal care, and the study will not change the treatment you receive unless your doctor discusses it with you.
What are the possible benefits and risks of participating?
The potential benefit of participating in this study is that it may provide your doctors with more precise information about your cancer, which could help you make a better-informed decision about chemotherapy. However, this will not necessarily lead to a change in your treatment plan, as the final decision will always be made by you and your doctor. There are no direct risks to you as a participant since the study uses your existing tumour sample and does not involve additional treatments.
Where is the study run from?
The study is being conducted at University Hospital Birmingham (UK), which will act as the main hub. Other sites in the West Midlands will also be involved in collecting data.
When is the study starting and how long is it expected to run for?
April 2023 to September 2026
Who is funding the study?
The study is funded by an AI in Health and Care Award from the Department of Health and Social Care (UK)
Who is the main contact?
Dr Susan Fotheringham, susan.fotheringham@oxfordbio.com
Contact information
Principal Investigator
Nuffield Division of Clinical and Laboratory Sciences | Level 4, Academic Block, John Radcliffe Infirmary, Headington
Oxford
OX3 9DU
United Kingdom
 ORCID ID |
0000-0001-7811-6722 |
|---|---|
| Phone | +44 300 304 7777 |
| david.kerr@ndcls.ox.ac.uk |
Principal Investigator
Queen Elizabeth Hospital, Mindelsohn Way
Birmingham
B15 2GW
United Kingdom
| Phone | +44 121 371 3603 |
|---|---|
| Victoria.Kunene@uhb.nhs.uk |
Public, Scientific
1 Robert Robinson Avenue, The Oxford Science Park
The Oxford Science Park
Oxford
OX4 4GA
United Kingdom
| ORCID ID |
0000-0001-5440-8747 |
|---|---|
| Phone | +44 1865784742 |
| susan.fotheringham@oxfordbio.com |
Study information
| Study design | Multi-centre interventional operational feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic, Other, Treatment |
| Participant information sheet | 46005_PIS[ClinicianInformationSheet]_v2.4_04March2024.pdf |
| Scientific title | Prognostic value of ploidy and digital tumour-stromal morphometric analyses for guiding chemotherapy treatment for Stage II/III Colon Cancer Patients |
| Study acronym | ONCOPROG_AI |
| Study objectives | Current study objectives as of 11/09/2025: Does the provision of the OncoProg test result inform the clinician/patient's decision about the uptake of adjuvant chemotherapy? This study will: Assess the differences, if any, in treatment recommendation for CRC Stage II and Stage IIIA or Stage IIIB (T1-3N1) patients, before and after the provision of OncoProg results Demonstrate the health-economic benefit of adopting OncoProg as a tool for guiding chemotherapy treatment for CRC Stage II and Stage IIIA or Stage IIIB (T1-3N1) Health condition(s) or problem(s) studied Cancer: Stage II (T3/T4 ) or stage IIIA (T1-3N1) or Stage IIIB (T1-3N1) colorectal carcinoma (histological diagnosis) _____ Previous study objectives: Does the provision of the OncoProg test result inform the clinician/patient's decision about the uptake of adjuvant chemotherapy? This study will: Assess the differences, if any, in treatment recommendation for CRC Stage II and Stage IIIA patients, before and after the provision of OncoProg results Demonstrate the health-economic benefit of adopting OncoProg as a tool for guiding chemotherapy treatment for CRC Stage II and Stage IIIA |
| Ethics approval(s) |
Approved 15/03/2024, East of England REC (Equinox House, Nottingham, NG2 4LA, United Kingdom; +44 207 104 8084; cambridgesouth.rec@hra.nhs.uk), ref: 23/EE/0227 |
| Health condition(s) or problem(s) studied | Cancer: Stage II (T3/T4 ) or stage IIIA (T1-3N1) colorectal carcinoma (histological diagnosis) |
| Intervention | This study involves the use of the digital biomarker test OncoProg to assess the cancer recurrence risk of patients and modification of treatment pathways accordingly. The use of OncoProg is compared to SOC (no test). This is a one-arm study in which all patients are introduced to the OncoProg test and given the option for this test to be used in their treatment planning. Once the patient has consented to enrolment in the study, their tumour tissue is processed to allow assessment using the OncoProg test. The OncoProg test is conducted on the processed tissue and the results of the test are recorded. The OncoProg results are then sent to the Oncologist for review alongside other SoC test results (as SoC patients will have a set of standard baseline blood tests to measure their full blood cell counts, blood clotting, kidney and liver function, etc). At this point, clinicians will be asked to record what adjuvant treatment they would aim to prescribe, based on the conventional information made available to them, e.g., standard morphological pathology data, mismatch repair status, performance status and comorbidities (other medical history). The oncologist will consider the OncoProg results alongside SoC test results and record whether OncoProg test results affect their chemotherapy recommendations and if so what changes to recommendations would be made. During the clinical appointment where the Oncologist and patient discuss treatment options, the treatment will be agreed upon based on evidence of SoC data. The OncoProg result will then subsequently be discussed by the patient and oncologist and the oncologist shall record if any change in treatment is agreed with the patient and record the nature of that change. The oncologist and the patient will then be asked to complete an acceptability questionnaire to record their views on the use of OncoProg for treatment decision-making. The use of OncoProg is a one-off test before treatment is planned (observation i.e. no treatment after surgery as the patient is at low risk of recurrence or chemotherapy if the patient is at high risk of recurrence). The use of the OncoProg test results in treatment planning and the opinions of both the oncologist and patient will be recorded to achieve the study objectives. There is no planned follow-up once this information has been recorded. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | OncoProg |
| Primary outcome measure | The treatment regimen decided upon after the OncoProg results are available is measured using the data captured on the case report form (CRF) about the agreed treatment regimen between the medical oncologist and the patient, which is documented in the post-OncoProg CRF |
| Secondary outcome measures | Current secondary outcome measures as of 11/09/2025: 1. Demonstrate the health economic benefit of adopting OncoProg as a tool for guiding chemotherapy treatment for CRC Stage II and Stage IIIA or Stage IIIB (T1-3N1) measured using patient healthcare utilisation data/CRF data at the end of the study 2. Acceptability to patient and clinician measured using acceptability questionnaires at the end of the study _____ Previous secondary outcome measures: 1. Demonstrate the health economic benefit of adopting OncoProg as a tool for guiding chemotherapy treatment for CRC Stage II and Stage IIIA measured using patient healthcare utilisation data/CRF data at the end of the study 2. Acceptability to patient and clinician measured using acceptability questionnaires at the end of the study |
| Overall study start date | 01/04/2023 |
| Completion date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 270 |
| Key inclusion criteria | Current inclusion criteria as of 11/09/2025: 1. Stage II (T3/T4 ) or stage IIIA (T1-3N1) or Stage IIIB (T1-3N1) colorectal carcinoma (histological diagnosis) 2. Age >18 years 3. The patient is considered fit enough to be considered for fluoropyrimidine (FP) based systemic chemotherapy as treatment for colorectal cancer, in the adjuvant setting 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements and give clearly documented consent 5. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial _____ Previous inclusion criteria: 1. Stage II (T3/T4 ) or stage IIIA (T1-3N1) colorectal carcinoma (histological diagnosis) 2. Age >18 years 3. The patient is considered fit enough to be considered for fluoropyrimidine (FP) based systemic chemotherapy as treatment for colorectal cancer, in the adjuvant setting 4. In the Investigator’s opinion, is able and willing to comply with all trial requirements and give clearly documented consent 5. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial |
| Key exclusion criteria | 1. Any known contraindications to 5FU based chemotherapy 2. Pregnancy or breast-feeding 3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 4. Rectal tumours that have been treated with chemo-radiotherapy prior to surgery 5. Patients that have been treated with chemotherapy prior to surgery |
| Date of first enrolment | 02/09/2024 |
| Date of final enrolment | 30/03/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Edgbaston
Birmingham
B15 2TH
United Kingdom
Walsall
WS2 9PS
United Kingdom
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Worcester
WR5 1DD
United Kingdom
Sponsor information
Industry
1 Robert Robinson Avenue, The Oxford Science Park
The Oxford Science Park
Oxford
OX44GA
England
United Kingdom
| Phone | +44 1865784742 |
|---|---|
| OncoProg@oxfordbio.com | |
| Website | https://www.oxfordbio.com/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Department of Health & Social Care, DH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.4 | 04/03/2024 | 02/09/2024 | No | Yes |
| Participant information sheet | version 3.3 | 04/03/2024 | 02/09/2024 | No | Yes |
| Protocol file | version 16.1 | 19/10/2023 | 02/09/2024 | No | No |
| Protocol file | version 16.3 | 02/06/2025 | 11/09/2025 | No | No |
Additional files
Editorial Notes
11/09/2025: The following changes were made to the trial record:
1. Uploaded protocol v16.3 (not peer-reviewed) as an additional file.
2. The study objectives were changed.
3. The secondary outcome measures were changed.
4. The inclusion criteria were changed.
5. The study participating centres were updated.
6. The plain English summary was updated to reflect these changes.
09/09/2025: The date of final enrolment was changed from 30/09/2025 to 30/03/2026.
28/08/2024: Trial's existence confirmed by NHS HRA.
