Cancer: Stage II (T3/T4 ) or stage IIIA (T1-3N1) colorectal carcinoma (histological diagnosis) Cancer
Conditions
Interventions
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
Sponsors
Oxford Cancer Biomarkers Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactSusan Fotheringham
Outcome results
None listed