Global Retinoblastoma Presentation (2024) and Outcome (2027) Studies.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 8,000
- 试验地点
- 1
- 主要终点
- To investigate the clinical stage at time of diagnosis of treatment-naïve children with Rb who present to treatment centers across the world in 2024.
研究概览
简要总结
The Global Retinoblastoma Presentation (2024) and Outcome (2027) Studies aim to understand how retinoblastoma (Rb), a type of eye cancer in children, presents worldwide and how well treatments work over time. Retinoblastoma is a serious disease that, if untreated, can spread and become fatal. Past studies have shown that children in low-income countries are often diagnosed later and have worse survival rates than those in high-income countries.
This new study, organized by an international research group, will collect data from treatment centers in many countries. It has two phases:
Phase 1: 1-year cross sectional data collection and analysis of all treatment-naïve children with retinoblastoma presenting to Rb treatment centres across the world in 2024. Data will be collected by each participating center during 2024 and then submitted for analysis.
Phase 2: 3-year prospective data collection and analysis of children diagnosed in treatment centers in 2024 (i.e. Phase I). Data will be collected by each participating center from January 1 2024 to December 31 2026, and submitted for analysis in early 2027.
The study will include only new cases diagnosed in 2024, ensuring that essential data like country of residence, sex, and which eye(s) are affected is recorded. Patients who were diagnosed or treated before 2024 will not be included.
Researchers will analyze data to compare results across income levels, countries, and treatment centers. The findings will help improve early detection and treatment strategies, potentially saving more lives.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Month(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Treatment-naïve patients with retinoblastoma who presented for diagnosis and treatment of their condition in
- •The following are obligatory data in order for a patient to be included in the study: Patient country of residence.
- •Patient sex.
- •Right/left/both eyes involved at time of diagnosis.
- •For the 2027 outcome study, additional data on survival (live/dead) is obligatory.
- •Example of cases to be included in the study (for all examples below, data on country of residence, sex and laterality are obligatory): Patient diagnosed with retinoblastoma during 2024 and received first treatment in
- •Patient diagnosed with retinoblastoma during 2024 and was not treated at all due to treatment abandonment.
- •Patient that presented to a treatment center during 2024 after receiving initial treatment elsewhere during 2024.If the obligatory data (country of residence, sex and laterality) can be traced and recorded, the patient can be included.
排除标准
- •Example of a cases to be excluded from the study: Patient for which data on country of residence and /or sex and /or laterality are missing.
- •A patient diagnosed and treated before 2024 and then came for additional treatment for the same or fellow eye.
- •Patient that presented to a treatment center in 2024 after receiving primary treatment elsewhere before 2024.
结局指标
主要结局
To investigate the clinical stage at time of diagnosis of treatment-naïve children with Rb who present to treatment centers across the world in 2024.
时间窗: At time of diagnosis
次要结局
- To investigate the treatment outcome of children with Retinoblastoma who were diagnosed in treatment centers across the world in 2024 & followed up for 3 years until 2027(At 36 months)
研究者
Dr Venkata Rama Mohan Gollamudi
Tata Memorial Hospital