A US Multi-Site Observational Study in Patients With Unresectable And Metastatic Melanoma: The OPTIMIzE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 408
- 试验地点
- 62
- 主要终点
- Patterns of Care
研究概览
简要总结
This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.
详细描述
This is a non-interventional, observational study with the primary objective to assess and describe "real world" patterns of care in the treatment of patients with unresectable or metastatic melanoma. A sample size of 1,600 prospective patients will provide sufficient information to explore this primary objective. There will be no forced number of patients enrolled into a specific treatment cohort. Setting or controlling specific treatment enrollment cohort counts would invalidate the results of the primary objective of the study. No primary hypothesis is being tested.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Prospective cohort patients:
- •Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in US)
- •Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal acral-lentiginous, leptomeningeal disease)
- •Age ≥ 18 years at time of entry into study
- •Patients must be actively receiving or scheduled to receive systemic treatment (any line, eg, first, second, third line [including investigational drugs]).
- •For patients initiating new treatment, treatment must be started within 28 days after signing informed consent.
- •For patients currently receiving treatment, patients must enroll within the first 21 days of starting new treatment
- •Retrospective cohort patients:
- •Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma (including mucosal, uveal, acral-lentiginous, leptomeningeal disease)
- •Age ≥ 18 years at time of unresectable or metastatic melanoma diagnosis
- •Initiated therapy for unresectable or metastatic melanoma within 4 years prior to approval of ipilimumab (first immune checkpoint inhibitor therapy approved in US)
- •March 25, 2007 - March 24, 2011
- •One year of follow-up data is required from date of therapy initiation, if a patient passed away within the one year of follow-up; such patients are still eligible and the date of death will be collected.
- •If retrospective patients have at least one year of follow-up data and are then treated with immuno-oncology, immune checkpoint inhibitor therapy, or targeted therapy, these patients will be analyzed separately.
排除标准
- •Prospective patients:
- •Patients participating in a clinical study that does not allow enrollment into a non interventional study or clinical studies in which the investigational treatment is blinded
- •Patients who started new treatment > 21 days
- •Patients who enrolled in study but did not initiate treatment before 28 days
- •Patients with current malignancies (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) that requires additional systemic therapy
结局指标
主要结局
Patterns of Care
时间窗: Up to 5 years
To assess the selection and sequencing of drugs and practice patterns used to treat unresectable and metastatic melanoma (e.g. immune checkpoint agents, targeted agents, or combination therapies) in a real-world setting. Reasons for initial treatment decisions across and between drug classes, changes in treatment, and discontinuation will be recorded (e.g. lack of benefit, safety, cost, or other barriers to care).
Demographics
时间窗: Up to 5 years
Baseline characteristics (age, gender, race/ethnicity)
Overall Survival
时间窗: Up to 5 years
To estimate overall survival in patients receiving therapy for unresectable or metastatic melanoma some statistical measurements and actual survival will be used.
Disease Characteristics
时间窗: Up to 5 years
Disease characteristics (date of diagnosis, disease stage, performance status)
次要结局
- Work Productivity and Activity Impairment: General Health (WPAI:GH)(Up to 12 months)
- Healthcare Resource(up to 5 years)
- Functional Assessments of Cancer Therapy-Melanoma (FACT-M)(Up to 12 months)
- European Quality of Life-5 Dimensions (EQ-5D)(Up to 12 months)
- The Caregiver Quality of Life Index - Cancer (CQOLC)(Up to 12 months)