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Multi-center, single-group, retrospective confirmatory clinical trial to evaluate the effectiveness of nProfiler® OlivA G for gastric cancer lesion detection

Multicenteral, single-group, retrospective confirmatory clinical performance test to evaluate the effectiveness of pathological diagnosis assistant software II (nProfiler® OlivA G) for detection of cancer lesions in WSI digitally scanned H&E (hematoxylin-eosin) slides of postoperative gastric cancer patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0008827
Enrollment
105
Registered
2023-09-25
Start date
2023-06-19
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

None listed

Interventions

None listed

Sponsors

Novomics
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Sample providers criteria: Select the sample (Slide and WSI) from gastric cancer patients after gastrectomy - FFPE samples from gastric cancer patient after gastrectomy * Slide - H&E stained slide stored to index formalin-fixed paraffin-embedded (FFPE) sample - Slides under proper conditions with pathologists confirmation * WSI(Whole-Slide Image) - WSI scanned with a certified scanner - WSI under good conditions (focus, no artifacts) with pathologists confirmation - WSI with the information(collected tissue area and diagnostic criteria)

Exclusion criteria

Exclusion criteria: Exclusion Criteria - Patients not diagnosed as gastric cancer (adenocarcinoma) - Gastric cancer patients without gastrectomy - Gastric cancer patients who have not undergone gastrectomy between 2010 and 2021 Sample Exclusion Criteria: - FFPE samples without gastric cancer lesion * Slide - Slides unable to read by pathologists - Slides unable to create WSI due to its bad conditions * WSI(Whole-Slide Image) - WSI scanned with an unauthorized scanner - WSI with annotations by the pathologists - WSI unable to read due to out of focus, artifacts, etc.

Design outcomes

Primary

MeasureTime frame
IoU(Intersection over Union)—

Secondary

MeasureTime frame
Percentage (%) of IoU (Intersection over Union) value greater than 0.7;DSC (Dice Similarity Coefficient);Efficiency in selection of sampling location—

Countries

Korea, Republic of

Contacts

Public ContactHYUNKI KIM

Yonsei University

kimhyunki@yuhs.ac+82-2-2228-2621

Outcome results

None listed

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