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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05102994
Other study ID # 2021-VRL-diagnosis
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 10, 2021
Est. completion date June 1, 2022

Study information

Verified date November 2021
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date June 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
mutation test
detect the tumor-related mutation in introcular fluid

Locations

Country Name City State
China Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the result of mutation test any mutation detect in intraocular fluild recorded as ctDNA+ at baseline, before treatment
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