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Testing the MitProfiler tool for detecting and counting dividing cells in stained tissue samples

Validation of the MitProfiler algorithm for the detection and quantification of mitotic figures in haematoxylin and eosin-stained tissue sections

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN16858627
Enrollment
500
Registered
2025-09-19
Start date
2025-08-13
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Sarcoma, melanoma, carcinoma, carcinoid Cancer

Interventions

This observational study involves comparing the blinded counts of mitotic figures in archived hematoxylin and eosin (H&E) sections with an automated mitotic counting algorithm.

Sponsors

Histofy Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with haematoxylin and eosin-stained tissue sections from tumour types: 1. Breast cancer 2. Neuroendocrine tumour 3. Melanoma (including uveal melanoma) 4. Soft tissue sarcoma 5. Leiomyoma 6. Lung cancer 7. Glioblastoma 8. Meningioma 9. Thyroid cancer 10. Retinoblastoma

Exclusion criteria

Exclusion criteria: Haematoxylin and eosin-stained tissue section slides are unavailable

Design outcomes

Primary

MeasureTime frame
Interobserver variation of mitotic counts measured using data generated by the MitProfiler algorithm and human pathologists at one timepoint

Secondary

MeasureTime frame
Time taken to produce mitotic counts measured using data generated by the MitProfiler algorithm and human pathologists at one timepoint

Countries

England, United Kingdom

Contacts

Public ContactDavid Snead
d.snead@histofy.ai+44 (0)2476968649

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026