A Single-arm Observational Study to Characterize the Epidemiological Profile of Patients With IDH-mutant Diffuse Gliomas Diagnosed From 2021 in Brazil - BRIGHT Study (LACOG 0425)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 350
- 试验地点
- 12
- 主要终点
- Epidemiological profile of patients with IDH-mutant diffuse gliomas
研究概览
简要总结
This is a real-world, retrospective, non-interventional, single-arm, multi-center Brazilian study that will include patients diagnosed with IDH-mutant diffuse glioma in Brazil from 2021. Eligible patients will be included in this study to have their medical charts data collected by site personnel. Included patients won´t be requested to attend protocol-specific visits and treatment decisions and disease management will be at the investigator's discretion
详细描述
This study is designed to describe the epidemiological, anti-cancer treatment and clinical outcomes of patients with IDH-mutant diffuse glioma in Brazil. Patients ≥ 12 years old diagnosed with IDH-mutant diffuse gliomas from 2021 will be included. In the baseline medical chart evaluation, data on epidemiology, pathological, treatment patterns, toxicities, and clinical outcomes will be collected. LACOG (Sponsor) will be responsible for managing data from this study, including quality verification. Manually entered data will be captured via EDC using eCRFs. The EDC system used in this study will be REDCap (Research Electronic Data Capture) - that meets the established standards approved for the safety of health information and is validated. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for continuous data downloads for common statistical packages; and 4) procedures for data integration and interoperability with external sources. The system also meets ICH guidelines on electronic handling of study data and will be available for audit upon request. Patient confidentiality will be strictly maintained.
An informed consent form will be offered to all living patients. The consent will be unnecessary in patients that could not be reached or that have passed away (died) as per regulation Res. CNS 466/12 item IV.8. Consent will be obtained from legal guardians for patients between the ages of 12 and 17 years old as per Brazilian regulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients (aged 12 years or older);
- •Histologically confirmed diagnosis of diffuse glioma from 2021;
- •Confirmed IDH mutation identified by IHC or PCR/NGS;
- •Willing and able to provide written informed consent, applicable to living patients. In case of patients <18 years of age, their legal guardians should provide an written informed consent
排除标准
- •Since the study is observational, there are no extensive Exclusion Criteria, but the following criteria excludes patients from the study to ensure data collected by be analyzed from a broader context and compared to other studies of this kind:
- •Patients without medical record available (lost, empty or irretrievable clinical information).
- •Living patients and/or legal guardians of patients <18 years of age who did not accept or withdrew their consent from the study.
研究组 & 干预措施
IDH-mutant diffuse glioma cohort
Male or female patients aged 12 years or older histologically confirmed diagnosis of diffuse glioma from 2021 and confirmed IDH mutation identified by IHC or PCR/NGS.
结局指标
主要结局
Epidemiological profile of patients with IDH-mutant diffuse gliomas
时间窗: Baseline
Characterization of demographic and socioeconomic characteristics, including age, weight, height, race, educational level, income, marital status, living status, and risk factors
次要结局
- Progression-Free Survival (PFS)(From date of diagnosis up to at least 30 months.)
- Overall Survival (OS)(From date of diagnosis up to at least 30 months.)
- Objective Response Rate (ORR)(Up to 30 months.)
- Treatment Patterns and Sequencing(Up to 30 months.)
- Dose Reduction and Discontinuation Rates(up to 30 months)
- Time to Next Intervention (TTNI)(Up to 30 months.)
- Interval Between Last Surgery and First Systemic Therapy or Radiotherapy(Baseline/up to 30 months)
- Time From Initial Diagnosis to First Systemic or Radiotherapy Initiation(Baseline/up to 30 months)
- Prevalence of Seizures at First Systemic Therapy(up to 30 months)
- Karnofsky Performance Status (KPS) Score(Baseline/up to 30 months)
- Karnofsky Performance Status (KPS) Deterioration(up to 30 months)
- Frequency and Results of Molecular Testing(Baseline)