Is the use of digital pathology in routine diagnosis reliable and safe in comparison to standard microscopy?
- Conditions
- Histopathological diagnosisNot Applicable
- Registration Number
- ISRCTN14513591
- Lead Sponsor
- niversity Hospital Coventry and Warwickshire (UHCW) NHS Trust
- Brief Summary
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38233108/ (added 15/05/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2024
Current participant inclusion criteria as of 17/03/2022:
Histopathology samples:
Case identification and selection will take place between September 2019 - October 2021 at five participating NHS histopathology departments. All samples are collected for the purpose of routine histopathology reporting and only entered into the validation study on completion of their clinical review at the respective NHS participating site, with the following specification:
1. Breast (Belfast, Lincoln & Nottingham) – A total of 600 sequential samples including 200 cancer screening biopsies enriched with at least 10% resected tumours (moderately difficult) and 10% difficult cases: low grade ductal carcinoma in situ, atypical hyperplasia, screening category B3 and B4, lesions with calcium oxalate (Weddellite calcification), sclerosing and papillary lesions, and micrometastases.
2. GI (Coventry, Belfast & Nottingham): – A total of 600 sequential samples including 200 cancer screening biopsies enriched with at least 10% resected tumours (moderately difficult) and 10% difficult: oesophageal dysplasia, polyp cancers, inflammatory bowel disease, minimal change colitis, graft versus host disease, giardiasis, cytomegalovirus, H. pylori and herpes virus infection.
3. Skin (Coventry, Belfast & Lincoln) : A total of 600 sequential samples enriched with at least 10% non-basal cell carcinoma cancer resections (moderately difficult) and 10% difficult: sentinel nodes, dysplastic naevi, spitz naevi, lentigo maligna, early and desmoplastic melanoma, herpes virus infection, leischmaniasis, leprosy, amyloid, angioscaroma, and Kaposis sarcoma.
4. Renal (Coventry, Nottingham & Oxford): A total of 200 sequential native biopsies for glomerular, tubulointerstitial and vascular disease and transplant biopsies for graft rejection. No enrichment is planned in the renal biopsy group as all of these biopsies are difficult to report.
Staff (for the qualitative part of the study):
Staff employed at the participating sites, including any of the following:
1. Pathologists
2. Trainee doctors
3. Biomedical scientists
4. Biomedical assistants
5. Advanced practitioners
6. Medical laboratory assistants
Previous participant inclusion criteria:
Histopathology samples:
Case identification and selection will take place between January 2019 – January 2022 at five participating NHS histopathology departments. All samples are collected for the purpose of routine histopathology reporting and only entered into the validation study on completion of their clinical review at the respective NHS participating site, with the following specification:
1. Breast (Belfast, Lincoln & Nottingham) – A total of 600 sequential samples including 200 cancer screening biopsies enriched with at least 10% resected tumours (moderately difficult) and 10% difficult cases: low grade ductal carcinoma in situ, atypical hyperplasia, screening category B3 and B4, lesions with calcium oxalate (Weddellite calcification), sclerosing and papillary lesions, and micrometastases.
2. GI (Coventry, Belfast & Nottingham): – A total of 600 sequential samples including 200 cancer screening biopsies enriched with at least 10% resected tumours (moderately difficult) and 10% difficult: oesophageal dysplasia, polyp cancers, inflammatory bowel disease, minimal change colitis, graft versus host disease, giardiasis, cytomegalovirus, H. pylori and herpes virus infection.
3. Skin (Coventry, Belfast & Lincoln) : A total of 600 sequential samples
Current participant exclusion criteria as of 17/03/2022:
1. Cases with either broken or missing slides
2. Cases with missing clinical data
3. Megablocks or oversized slide sets
4. Cases where a prior sample is important to the interpretation of the study sample
Previous participant exclusion criteria:
Cases with either broken or missing slides
Study & Design
- Study Type
- Other
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intra-pathologist agreement between digital pathology and light microscopy diagnoses, measured by comparing the concordance between the results of pathologists’ diagnoses made by assessment of LM of breast, GI, skin and renal samples, with the same pathologists’ diagnoses of the same samples (intra-rater (pathologists) reliability) using DP. <br>There will be three categories for the level of agreement; complete agreement, clinically unimportant difference and clinically important difference. For each sample, three sets of agreements will be reported:<br>1. Whether for each pathologist’s DP and LM diagnoses agree<br>2. Whether each of the four DP diagnoses agree with the ground truth (GT)<br>3. Whether each of the four LM diagnoses agree with the GT.<br>This will be completed after all results have been completed and analysed (20-30 months)
- Secondary Outcome Measures
Name Time Method