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Pathology Artificial-Intelligence Clinical Evaluation Study

A clinical utility study investigating the integration of machine learning algorithms into the colorectal cancer care pathway, from histopathology to the clinical multidisciplinary team

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN12706992
Enrollment
170
Registered
2024-10-15
Start date
2024-10-01
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer Cancer

Interventions

Pseudonymous digital images of histological slides generated as part of routine NHS care will be obtained with participant consent. Images will then be run through three different machine learning alg

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Clinical suspicion or confirmed diagnosis of colorectal adenocarcinoma of any stage 2.1. Participant is scheduled for anti-cancer treatment including one or more of the: 2.1.1. Resection of primary tumour or metastatic disease 2.1.2. Systemic anti-cancer therapy including chemotherapy, biological therapy or immunotherapy in either the neoadjuvant, adjuvant or metastatic settings 2.1.3. Local radiotherapy or Stereotactic Ablative Radiotherapy (SABR) tumour ablative therapies 3. The patient is scheduled for palliative care only 4. Age >18 years 5. The participant is willing to comply with all study requirements

Exclusion criteria

Exclusion criteria: 1. 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. 2. Treatment with chemoradiotherapy prior to diagnostic biopsy related to the cancer under study in the past 12 months.

Design outcomes

Primary

MeasureTime frame
The efficacy of integrating machine learning algorithms into the digital pathology and clinical decision pathway for CRC will be measured using questionnaire data obtained from clinical care and pathologist teams after a decision on real-world treatment has been made

Secondary

MeasureTime frame
Conclusions on whether algorithm analyses would have changed real-world treatment recommendations will be derived from percentage changes of theoretical treatment recommendations captured from questionnaires completed by clinical care and pathologist teams at the end of the study

Countries

England, United Kingdom

Contacts

Public ContactChen-Chun Pai
chen-chun.pai@medsci.ox.ac.uk+44 (0)1865617043

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026