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Mutation Detection for VRL

Sun Yat-sen University logo

Sun Yat-sen University

Status

Unknown

Conditions

Uveitis
Vitreoretinal Lymphoma

Treatments

Diagnostic Test: mutation test

Study type

Observational

Funder types

Other

Identifiers

NCT05102994
2021-VRL-diagnosis

Details and patient eligibility

About

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

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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