Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03992768
Other study ID # HCT-P002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 12, 2019
Est. completion date September 30, 2021

Study information

Verified date November 2022
Source Hamamatsu Photonics K.K.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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)


Recruitment information / eligibility

Status Completed
Enrollment 540
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
Detection of pathology features using whole slide imaging

Locations

Country Name City State
United States The Cleveland Clinic Foundation Cleveland Ohio
United States The Ohio State University Columbus Ohio
United States Washington University Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Hamamatsu Photonics K.K.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Percentage Agreement of Repeatability and Reproducibility Within Scanner, Between Scanners, and Sites. Repeatability and reproducibility of WSI were evaluated using the Average Positive Agreement Rate. Using a comparison of two reads with four possible outcomes (a=both reads detect the feature; b=read 1 fails to detect the feature; c=read 2 fails to detect the feature; d=both reads fail to detect the feature), APA = 2a/(2a+b+c). APA was used to assess outcomes in the following substudies:
Scans within scanner (Intra-scanner Precision): Scans are repeated within the scanner at the site.
Scanners within site (Inter-scanner Precision): Scans are repeated among the scanners at the site
Scans between Sites (Inter-site Precision): Scans are repeated within the scanner at the different sites.
1 day
See also
  Status Clinical Trial Phase
Recruiting NCT06035250 - AI Prediction of Gastric Cancer Response to Neoadjuvant Chemotherapy
Not yet recruiting NCT04788927 - Development of a Predictive Model for the Risk of Metastatic Disease in PPGLs, a Retrospective Cohort Study
Not yet recruiting NCT05565677 - Prognostic Value of Lung Cancer MicroAnatomy in 3D
Recruiting NCT05191433 - Effects of Mechanical Ventilation on the Diaphragm in COVID-19 Intensive Care Patients. A Post-mortem Pathology Study
Recruiting NCT04809025 - Comparation of Endoscopic Biopsy and Postoperative Specimen for the Molecular Diagnosis of Gastric Cancer
Recruiting NCT05218460 - Evaluation of Methodological and Technical DEvelopmeNts to Improve the Quality and Comfort of Magnetic Resonance Imaging Exam on Voluntary Subjects N/A
Recruiting NCT02436122 - Impact of Preoperative HbA1c Levels on Pathologic Features and Oncological Outcomes in the Patients With Prostate Cancer N/A
Not yet recruiting NCT01569555 - Significant Pathology Associated With Crossed Leg Sign N/A
Not yet recruiting NCT01569542 - Crossed Leg Sign and it's Correlation With Significant Pathology N/A
Active, not recruiting NCT01993199 - Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors N/A
Recruiting NCT04879056 - Instrument Precision Study for Validation of PIPS 5.1
Completed NCT03986268 - Vitamin D Can Increase Pathological Response of the Breast Cancer Patients Treated With Neoadjuvant Therapy N/A
Completed NCT05983003 - Research on Identifying and Treatment Prognosis of Chronic Rhinosinusitis Based on Image and Sequencing Data
Completed NCT03991468 - Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System N/A
Completed NCT04356768 - Histological Analysis of Sacrococcygeal Pilonidal Sinus Specimens
Recruiting NCT03230994 - Cooperative Adenomyosis Network
Completed NCT01628250 - Laparoscopic Complete Mesocolic Excision on Colon Cancer N/A
Not yet recruiting NCT04956601 - Adjuvant Radiotherapy in Patients With Early Endometrial Cancer N/A
Completed NCT02971072 - Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy N/A
Completed NCT03872362 - Radiomics Multifactorial Biomarker for Pulmonary Nodules