College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia
Queensland Eye Institute, Brisbane, Queensland, Australia.
BMJ Open. 2022 Jul 28;12(7):e060701. doi: 10.1136/bmjopen-2021-060701.
Vitreoretinal lymphoma is a rare ocular cancer with high morbidity and mortality despite treatment. Diagnosis by cytopathology is often delayed, and various molecular and image-based investigations have been developed. Diverse treatments are used, but there is a limited medical evidence to differentiate their effectiveness. We designed an international registry that would collect diagnostic, treatment and outcomes data, to establish new evidence for the management of this cancer.
The International Vitreoretinal B-Cell Lymphoma Registry will accrue data retrospectively for individuals aged 18 years or older, diagnosed with new or recurrent vitreoretinal B-cell lymphoma on or after 1 January 2020. A steering committee of subspecialised ophthalmologists identified 20 key clinical data items that describe patient demographics, tissue involvements, diagnostic testing, ocular and systemic treatments and treatment complications, and visual acuity and survival outcomes. Customised software was designed to permit collection of these data across a single baseline and multiple follow-up forms. The platform collects data without identifiers and at 3 month reporting intervals. Outcomes of the project will include: (1) descriptions of clinical presentations, and diagnostic and therapeutic preferences; (2) associations between clinical presentations, and diagnostics and treatments, and between diagnostics and treatments (assessed by ORs with 95% CIs); and (3) estimations of rates of vision loss, and progression-free and overall survival (assessed by Kaplan-Meier estimates).
The registry has received Australia-wide approval by a national human research ethics committee. Sites located outside Australia are required to seek local human research ethics review. Results generated through the registry will be disseminated primarily by peer-reviewed publications that are expected to inform clinical practice, as well as educational materials.
尽管进行了治疗，眼内淋巴瘤仍是一种罕见的眼部癌症，发病率和死亡率都很高。通过细胞学诊断通常会被延误，因此已经开发了各种基于分子和影像的检查方法。使用了不同的治疗方法，但对于区分它们的有效性的医学证据有限。我们设计了一个国际登记处，该登记处将收集诊断、治疗和结局数据，为管理这种癌症建立新的证据。
国际玻璃体内 B 细胞淋巴瘤登记处将回顾性地累积自 2020 年 1 月 1 日起新诊断或复发性玻璃体内 B 细胞淋巴瘤患者的 18 岁及以上个体的数据。由专门从事眼科亚专业的指导委员会确定了 20 个关键临床数据项目，这些项目描述了患者的人口统计学、组织受累情况、诊断检测、眼部和全身治疗以及治疗并发症，以及视力和生存结局。设计了定制软件，以便在单个基线和多个随访表格中收集这些数据。该平台收集无标识符数据，并以 3 个月的报告间隔收集数据。该项目的结果将包括：(1)描述临床表现、诊断和治疗偏好；(2)评估临床表现、诊断和治疗之间，以及诊断和治疗之间的相关性(通过 OR 和 95%CI 评估)；(3)估计视力丧失、无进展和总生存率(通过 Kaplan-Meier 估计评估)。
该登记处已获得澳大利亚全国人类研究伦理委员会的全国批准。位于澳大利亚境外的地点需要寻求当地人类研究伦理审查。通过该登记处生成的结果将主要通过同行评审的出版物传播，预计这些出版物将为临床实践提供信息，并提供教育材料。
