Mutation Detection for VRL

• Conditions: Vitreoretinal Lymphoma; Uveitis
• Interventions: Diagnostic Test: mutation test

• Registration Number: NCT05102994
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-10-17
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-02
• Study Start: 2021-11-10
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15
• Primary Completion: 2022-04-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VRL patients group	mutation test	Presenting clinical features suggestive for VRL with positive finding in laboratory exam
uveitis group	mutation test	Even if characterized as clinical features of presumed VRL, no positive laboratory investigations for lymphoma and well response to IMT

Primary Outcome Measures

Name	Time	Method
the result of mutation test	at baseline, before treatment	any mutation detect in intraocular fluild recorded as ctDNA+

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China