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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04695015
Other study ID # IRB00006761-M2020434
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 31, 2020
Est. completion date June 1, 2022

Study information

Verified date January 2021
Source Peking University
Contact Chun Zhang, MD/PHD
Phone +8618601031059
Email zhangc1@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to establish a standardized process for obtaining digital pathological image information of ocular tumors; use modern pathological techniques to obtain the co-expression information of multiple biomarkers in the pathological tissues of ocular tumors, and finally construct standardized digital ocular tumors with biomarkers Pathology image database.


Description:

This study is a prospective study. Patients with common and representative ocular tumors in the Department of Ophthalmology, Peking University Third Hospital, will be selected and enrolled after informed consent to collect basic clinical information, preoperative blood samples, and ocular tumors Obtain pathological image annotation data and genomics-related data from ocular tumor tissue specimens, use blood samples for genomics information analysis, provide multi-dimensional data for the development of artificial intelligence algorithms, and establish artificial intelligence-assisted image data for eye tumors Standardize the process and establish a multi-modal ocular tumor standardized database of "clinical information-tissue samples-pathological images-genomics data". The database and the diagnosis system are correlated with each other to provide optimal image data for later machine learning and related algorithm establishment, and finally the investigators will be completed the design of a new artificial intelligence-assisted diagnosis system for eye tumors.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Patients diagnosed with eye tumors and undergoing eye tumor surgery. 2. Patients sign informed consent for sample collection and sample transfer agreement, and can cooperate with long-term regular follow-up requirements. Exclusion Criteria: 1. Patients who are unable to undergo tumor surgery or retain samples due to various reasons . 2. Patients who are positive for hepatitis B, HIV, and syphilis. 3. Patient compliance is poor.

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Peking University

Outcome

Type Measure Description Time frame Safety issue
Primary To compare the diagnostic accuracy of OPAL and IHC for melanoma and other tumors. The result of OPAL automatic analysis will be compared with IHC manual counting analysis.The accuracy of the study will be declared "success" if OPAL automatic analysis meet more than 85% of the manual count for all antibody. Up to 24 weeks.
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