Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

Recruiting

• Conditions: Primary Vitreoretinal Lymphoma
• Interventions: Drug: Intravitreal injection of methotrexate

• Registration Number: NCT05950490
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This study intends to apply for the establishment of research beds, establish a Chinese PVRL research cohort, and carry out a to achieve the following research objectives:

The goal of this prospective observational study is to construct the diagnosis and treatment system for primary vitreoretinal lymphoma（PVRL）. The study is to achieve the following research objectives:

1. To establish a comprehensive diagnostic criteria for PVRL with high diagnostic efficiency and strengthen the PVRL diagnostic system;

2. To establish a standardized treatment pathway for PVRL and evaluate the efficacy and safety of treatment;

3. To screen the prognosis evaluation indicators, and to establish the follow-up process and prognosis evaluation system of PVRL；

4. To explore the pathogenesis of PVRL, specific tumor markers and drug therapeutic targets.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18
• Primary Completion: 2024-12
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Newly diagnosed PVRL patients admitted to the Ophthalmology or Hematology departments of Peking Union Medical College Hospital from 2022 to 2024;
• 18-75 years old;
• The diagnosis was confirmed by pathology, aqueous humor/vitreous IL-10/IL-6, vitreous flow cytometry and gene rearrangement.;
• HIV-Ab negative;
• Creatinine clearance > 50ml/min;
• Sign informed consent.

Exclusion Criteria

• Combined with other tumors;
• Uncontrolled active infections;
• Pregnant or lactating women;
• Antitumor therapy other than the protocol of this study was used.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Intravitreal injection of methotrexate	Cerebrospinal fluid IL-10 was normal
Group B	Intravitreal injection of methotrexate	Cerebrospinal fluid IL-10 was normal or elevated

Primary Outcome Measures

Name	Time	Method
Interleukin-10/Interleukin-6（IL-10/IL-6）	2.5 years	cerebrospinal

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China