NCT04695015

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

1.4 years

First QC Date

November 19, 2020

Last Update Submit

January 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Melanoma and Nevus

Patients diagnosed with melanoma or/and nevus on the skin around the eye before surgery.

Basal cell carcinoma;Squamous cell carcinoma;Sebaceous gland carcinoma

Patients diagnosed with basal cell carcinoma, squamous cell carcinoma, sebaceous gland carcinoma before surgery.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients from the Department of Ophthalmology, Peking University Third Hospital who has an eye tumor and undergoes surgery.

You may qualify if:

  • Patients diagnosed with eye tumors and undergoing eye tumor surgery.
  • Patients sign informed consent for sample collection and sample transfer agreement, and can cooperate with long-term regular follow-up requirements.

You may not qualify if:

  • Patients who are unable to undergo tumor surgery or retain samples due to various reasons .
  • Patients who are positive for hepatitis B, HIV, and syphilis.
  • Patient compliance is poor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

After the blood samples are treated with EDTA anti coagulation, the second-generation sequencing is performed from the DNA level and the RNA level to collect relevant genomics information, and establish an ocular tumor fusion genome database. Investigators will establish a complete sequencing data annotation database based on the existing tumor sequencing data annotation and analysis of soft nail sets and tumor sequencing data related public databases (such as the cosmic database).

MeSH Terms

Conditions

MelanomaCarcinoma, Basal CellSquamous Intraepithelial LesionsEye Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Basal CellMorphological and Microscopic FindingsPathological Conditions, Signs and SymptomsEye Diseases

Study Officials

  • Chun Zhang, MD/PHD

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Zhang, MD/PHD

CONTACT

Defu Wu, master

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 19, 2020

First Posted

January 5, 2021

Study Start

December 31, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

January 5, 2021

Record last verified: 2021-01