NCT05102994

Mutation Detection for VRL

The Diagnostic Value of Mutation Detection for VRL

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitreoretinal Lymphoma
• Uveitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	mutation test	detect the tumor-related mutation in introcular fluid

Timeline

• Start date: 2021-11-10
• Primary completion: 2022-04-01
• Completion: 2022-06-01
• First posted: 2021-11-02
• Last updated: 2021-11-15

Locations

1 site across 1 country: China