Mutation Detection for VRL

November 12, 2021 updated by: Dan Liang, Sun Yat-sen University

The Diagnostic Value of Mutation Detection for VRL

Vitreoretinal lymphoma (VRL) is a rare but aggressive masquerade syndrome, which would be easily confused with uveitis. The diagnostic gold standard remains the pathologic examination of ocular specimen with invasiveness and low sensitivity. To improve the safety and accuracy of VRL diagnosis, alternative techniques using intraocular fluid (IOF) samples are emerging. In this study, we aimed to test the diagnostic value of mutation analysis for VRL

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

chest CT, urinalysis, kidney, and liver function were routinely checked.

IL-10/IL-6 ratio, genetic mutation analysis and samples were IGH gene rearrangements were reviewed and analyzed retrospectively.

The diagnoses were identified after careful evaluation of treatment effects in follow-up. The diagnostic value including sensitivity, specificity, positive and negative predictive values, and test efficiency of genetic mutation analysis in diagnosing VRL were analyzed.

Furthermore, a validation group of patients including VRL and uveitis was selected to validate the diagnostic value of mutation analysis in the diagnosis of VRL. All the patients signed an informed consent and institutional review board approval was obtained. The study was performed in accordance with the tenets of the Declaration of Helsinki.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhongshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

suspected VRL or uveitis patients attending to our clinic

Description

Inclusion Criteria:

  • suspected VRL patients who had intraocular fluid for mutation test. And got a clear diagnose of VRL or uveitis afther having dianostic tests and follow-up treatment

Exclusion Criteria:

  • suspected VRL patients who lost in follow-up without a definitive diagnose, or whoever reluctance to participate our study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VRL patients group
Presenting clinical features suggestive for VRL with positive finding in laboratory exam
Diagnostic test: mutation test
detect the tumor-related mutation in introcular fluid
uveitis group
Even if characterized as clinical features of presumed VRL, no positive laboratory investigations for lymphoma and well response to IMT
Diagnostic test: mutation test
detect the tumor-related mutation in introcular fluid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the result of mutation test
Time Frame: at baseline, before treatment
any mutation detect in intraocular fluild recorded as ctDNA+
at baseline, before treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Dan D Liang, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 10, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

October 17, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-VRL-diagnosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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