Vitreoretinal LymphomaNCT05102994
Mutation Detection for VRL
An observational study of Vitreoretinal Lymphoma and Uveitis, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vitreoretinal Lymphoma, Uveitis
- What is being tested?
- mutation test
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: suspected VRL or uveitis patients attending to our clinic
Who may be able to join
- 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
Who cannot join
- suspected VRL patients who lost in follow-up without a definitive diagnose, or whoever reluctance to participate our study
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: The Diagnostic Value of Mutation Detection for VRL
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
Read the 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
- Being tested
- mutation test
- Keywords
- Vitreoretinal lymphoma, Uveitis, intraocular fluid, mutation
- Medical subject headings
- Intraocular Lymphoma, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutation testDiagnostic test
detect the tumor-related mutation in introcular fluid
| Study group | Role | What they receive |
|---|---|---|
| VRL patients group | Presenting clinical features suggestive for VRL with positive finding in laboratory exam Receives: Diagnostic Test: mutation test | |
| uveitis group | Even if characterized as clinical features of presumed VRL, no positive laboratory investigations for lymphoma and well response to IMT Receives: Diagnostic Test: mutation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the result of mutation test
any mutation detect in intraocular fluild recorded as ctDNA+
Measured: at baseline, before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start10 Nov 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreoretinal LymphomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Liang, Sun Yat-sen University
- Investigators
- Dan D Liang, PhD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102994
- Sponsor's protocol ID
- 2021-VRL-diagnosis
- Status last verified
- Nov 2021
- First submitted
- 17 Oct 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Mutation Detection for VRL
- ClinicalTrials.gov ID
- NCT05102994
- Acronym / sponsor ID
- 2021-VRL-diagnosis
- Conditions
- Vitreoretinal Lymphoma, Uveitis
- Keywords
- Vitreoretinal lymphoma, Uveitis, intraocular fluid, mutation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Nov 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRL patients group | – | Diagnostic Test: mutation testPresenting clinical features suggestive for VRL with positive finding in laboratory exam |
| uveitis group | – | Diagnostic Test: mutation testEven if characterized as clinical features of presumed VRL, no positive laboratory investigations for lymphoma and well response to IMT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- suspected VRL or uveitis patients attending to our clinic
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- suspected VRL patients who lost in follow-up without a definitive diagnose, or whoever reluctance to participate our study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mutation testdetect the tumor-related mutation in introcular fluid | Diagnostic test | VRL patients group, uveitis group |
Primary outcome
the result of mutation test
Time frame: at baseline, before treatment
any mutation detect in intraocular fluild recorded as ctDNA+
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan D Liang, PhD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitreoretinal Lymphoma and Uveitis, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the result of mutation test (time frame: at baseline, before treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.