Construction of Diagnosis and Treatment System for Primary Vitreoretinal Lymphoma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Primary Vitreoretinal Lymphoma

Treatments: Drug: Intravitreal injection of methotrexate

Study type: Observational

Funder types: Other

Identifiers

NCT05950490

2022-PUMCH-C-038

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Group A

Description:

Cerebrospinal fluid IL-10 was normal

Treatment:

Drug: Intravitreal injection of methotrexate

Group B

Description:

Cerebrospinal fluid IL-10 was normal or elevated

Treatment:

Drug: Intravitreal injection of methotrexate