Clinical trial · Observational
Multicentre Implementation and Validation of a Molecular Diagnostic for VitreoRetinal Lymphoma
DECODE VRL - Multicentric Implementation and Clinical Validation of Standardized, Innovative Molecular Diagnostics for VitreoRetinal Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this observational study is to gain new insights into the changes in proteins, genes and other molecular biological substances in the aqueous humour, vitreous humour, blood serum and, in rare cases, retina/choroid samples in patients with ocular lymphoma disease. The hope is that this will expand the understanding of the mechanisms of the disease and thus contribute to improved and simplified diagnosis and treatment strategies in the future. The aim is the inclusion of at least 220 patients during the study period. The main questions it aims to answer are: * to evaluate the diagnostic quality of extended molecular diagnostics (based on standard work-up) of vitreous samples for the specific VitreoRetinalLymphoma (a type of ocular lymphoma disease) diagnosis in comparison to standard work-up alone. * To monitor VRL patients as part of regular tumour follow-up over a period of 24 months to determine the value of biomarkers with regard to treatment response and development of recurrence in the eye. Similarly, the vitritis patients are followed up by telephone every six months for a period of 24 months, during which questions of any interim occurrence of a VRL or other cancerous tumors are asked according to a defined catalogue of questions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vitreoretinal Lymphoma | Primary Intraocular Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- To implement a standardised diagnostic work-up of vitreous samples from patients with suspected VRL
- timeFrame
- 6 years
- description
- The diagnostic work-up would be from patients with suspected VRL including NGS-based mutation and B-cell clonality analysis and quantification of miRNAs 19b, 21 and 92 for the participating ophthalmology centres.
- measure
- Rate of correct diagnosed VRL and vitritis with the use of extended molecular diagnostics versus standard work-up alone
- timeFrame
- 6 years
- description
- The evaluation of the diagnostic sensitivity and specificity of extended molecular diagnostics (based on standard work-up) of vitreous samples for VRL diagnosis in comparison to standard work-up alone.
- measure
- Rate of patients with VRL or vitritis within the follow up of 24 Months after diagnostics
- timeFrame
- 24 Months for each patient, all in all a 6 year frame for all patients.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical suspicion of the presence of VRL with indication for diagnostic vitrectomy. Clinical suspicion is based on the assessment of the treating physicians in the clinics participating in this study. * Age over 18 years. * Written informed consent to participate in the study. Exclusion Criteria: * Systemic chemotherapy for lymphoma within 3 months prior to vitrectomy. * Cortisone use within 2 weeks before vitrectomy, macular oedema, posterior synechiae, rubeosis iridis
References
Publications (0)
Data not yet available