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Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

NCT ID: NCT03992768

Last Updated: 2022-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-12

Study Completion Date

2021-09-30

Brief Summary

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The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging

Detailed Description

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The study will be conducted under the following 3 sub-studies:

1. Scans within Scanner (Intra-scanner precision substudy),
2. Scanners within a site (Inter-scanner precision substudy),
3. Scanners between sites (Inter-site precision substudy)

Conditions

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Pathology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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NanoZoomer Whole Slide Imaging

Whole slide imaging using the Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

Group Type EXPERIMENTAL

Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

Intervention Type DEVICE

Detection of pathology features using whole slide imaging

Interventions

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Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

Detection of pathology features using whole slide imaging

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Glass slides are screened for the known features and will be considered eligible for the study only if all of the following criteria apply:

* Slides are selected from cases in a consecutive manner starting with cases at least 1 year old since accessioning
* Slide is a glass cover-slipped surgical pathology slide of human tissue
* Slide is stained with hematoxylin and eosin (H\&E) or other stains
* Slide has the designated primary feature in the FOV, which is readily observable in its natural environment although the slide may also have one or more secondary features from the same magnification group in the FOV.
* Slide is available in the archives for use, or purchased commercially, is not damaged, has tissue on the slide which is still in good condition, has a stain that is not faded and otherwise passes all quality checks

Exclusion Criteria

Slides are to be excluded from the study if any of the following criteria apply:

* Slide is unable to be scanned, contains damaged tissue or has indelible markings
* Slide comes from an active (less than 1 year old) case
* Slide is from a patient who already has a slide enrolled in the study, only 1 slide per patient to be enrolled
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hamamatsu Photonics K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anil Parwani, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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Washington University

St Louis, Missouri, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HCT-P002

Identifier Type: -

Identifier Source: org_study_id