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Mutation Detection for VRL

NCT ID: NCT05102994

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-10

Study Completion Date

2022-06-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Vitreoretinal Lymphoma Uveitis

Keywords

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Vitreoretinal lymphoma Uveitis intraocular fluid mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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VRL patients group

Presenting clinical features suggestive for VRL with positive finding in laboratory exam

mutation test

Intervention Type DIAGNOSTIC_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

mutation test

Intervention Type DIAGNOSTIC_TEST

detect the tumor-related mutation in introcular fluid

Interventions

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mutation test

detect the tumor-related mutation in introcular fluid

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Dan Liang

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan D Liang, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2021-VRL-diagnosis

Identifier Type: -

Identifier Source: org_study_id