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
Secondary identifying numbers IRAS 330060
Submission date
28/08/2024
Registration date
11/09/2024
Last edited
09/09/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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 IIA). 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

Prof David Kerr
Principal Investigator

Nuffield Division of Clinical and Laboratory Sciences | Level 4, Academic Block, John Radcliffe Infirmary, Headington
Oxford
OX3 9DU
United Kingdom

ORCiD logoORCID ID 0000-0001-7811-6722
Phone +44 300 304 7777
Email david.kerr@ndcls.ox.ac.uk
Dr Victoria Kunene
Principal Investigator

Queen Elizabeth Hospital, Mindelsohn Way
Birmingham
B15 2GW
United Kingdom

Phone +44 121 371 3603
Email Victoria.Kunene@uhb.nhs.uk
Dr Susan Fotheringham
Public, Scientific

1 Robert Robinson Avenue, The Oxford Science Park
The Oxford Science Park
Oxford
OX4 4GA
United Kingdom

ORCiD logoORCID ID 0000-0001-5440-8747
Phone +44 1865784742
Email susan.fotheringham@oxfordbio.com

Study information

Study designMulti-centre interventional operational feasibility study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeDiagnostic, Other, Treatment
Participant information sheet 46005_PIS[ClinicianInformationSheet]_v2.4_04March2024.pdf
Scientific titlePrognostic value of ploidy and digital tumour-stromal morphometric analyses for guiding chemotherapy treatment for Stage II/III Colon Cancer Patients
Study acronymONCOPROG_AI
Study objectivesDoes 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) studiedCancer: Stage II (T3/T4 ) or stage IIIA (T1-3N1) colorectal carcinoma (histological diagnosis)
InterventionThis 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 typeDevice
Pharmaceutical study type(s)Not Applicable
PhaseNot Applicable
Drug / device / biological / vaccine name(s)OncoProg
Primary outcome measureThe 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 measures1. 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 date01/04/2023
Completion date30/09/2026

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit100 Years
SexBoth
Target number of participants270
Key inclusion criteria1. 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 criteria1. 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 enrolment02/09/2024
Date of final enrolment30/03/2026

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

University Hospital Birmingham
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
United Kingdom
Walsall Manor Hospital
Moat Road
Walsall
WS2 9PS
United Kingdom
The Royal Wolverhampton NHS Trust
New Cross Hospital
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Royal Stoke University Hospital
Newcastle Road
Stoke-on-trent
ST4 6QG
United Kingdom
Worcestershire Royal Hospital
Charles Hastings Way
Worcester
WR5 1DD
United Kingdom

Sponsor information

Oxford Cancer Biomarkers Ltd
Industry

1 Robert Robinson Avenue, The Oxford Science Park
The Oxford Science Park
Oxford
OX44GA
England
United Kingdom

Phone +44 1865784742
Email OncoProg@oxfordbio.com
Website https://www.oxfordbio.com/

Funders

Funder type

Government

Department of Health and Social Care
Government organisation / National government
Alternative name(s)
Department of Health & Social Care, DH
Location
United Kingdom

Results and Publications

Intention to publish date30/09/2027
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a peer-reviewed journal
IPD sharing planThe 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

Additional files

46005_PIS[ClinicianInformationSheet]_v2.4_04March2024.pdf
46005_PIS_v3.3_04March2024.pdf
46005_Protocol_v16.1_19Oct2023.pdf

Editorial Notes

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.