Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel® Wafer (Carmustine Implant) Used in Usual Medical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 272
- 试验地点
- 31
- 主要终点
- To evaluate the overall survival rate for patients treated with Gliadel Wafer
研究概览
简要总结
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
详细描述
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Data will be collected on the safety and effectiveness of treatment with Gliadel Wafer perioperatively and ongoing during regular office visits up to 3-years. Patients enrolled in this registry will be asked to complete a questionnaire (Functional Assessment of Cancer Therapy-Brain [FACT-Br]) about their well-being and clinicians will complete the Karnofsky Performance Status (KPS) during office visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent, by the patient or a legally acceptable representative, obtained before any registry-related activities are undertaken. The informed consent must be signed within 14 calendar days after surgery.
- •Male and female patients, greater than or equal to 18 years of age or age of majority in state of residence.
- •Patients planning to receive Gliadel Wafer, or having already received Gliadel Wafer and having signed consent to enroll in the registry within 14 calendar days after surgery for treatment of central nervous system (CNS) tumor(s), or are currently enrolled in another study where they received Gliadel Wafer.
- •Signed release form, by the patient or a legally acceptable representative, permitting abstraction of the patient's medical records at Baseline and during participation in the registry.
排除标准
- •The patient is enrolled in an interventional clinical trial, in which treatment for CNS tumor(s) is managed through a protocol that excludes Gliadel Wafer treatment.
- •Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry.
- •Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.
结局指标
主要结局
To evaluate the overall survival rate for patients treated with Gliadel Wafer
时间窗: up to 3 years
Time from Gliadel placement to death
To evaluate the progression-free survival rate for patients treated with Gliadel Wafer
时间窗: up to 3 years
Time from Gliadel placement to diagnosis of recurrent CNS tumor
To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer
时间窗: up to 3 years
Time from Gliadel placement to death due to CNS tumor
次要结局
- To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer.(up to 3 years)
- To evaluate change in patient health status over time via patient reported outcomes (PRO)(up to 3 years)
- To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer.(up to 3 years)
- To evaluate change in patient health status over time via a practitioner/proxy reported scale(up to 3 years)
- To evaluate the the reasons a physician does not insert Gliadel Wafers, in patients who were considered and consented for this Registry prior to the tumor resection procedure(up to 3 years)
- To evaluate events of interest (EOI) in patients treated with Gliadel Wafer.(up to 3 years)