Guardant360® Test-Related Clinical Outcomes in Patients Who Share Medical Records (GRECO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
To document the clinical outcomes of cancer patients who received the Guardant360® test and agree to share their records with Guardant Health.
详细描述
This is an observational study of clinical outcomes to be conducted in the United States. Patients with a diagnosis of Stage 3-4 advanced cancer who possess specific pathway mutations identified by the Guardant360® test will be eligible to enroll in the study. Patients will be recruited by telephone or email and/or through the Guardant Health Patient Portal to determine interest in the study. Should patients be interested in contributing to this registry study, they will be prompted to consent via a commercial service for patients to request, manage, and view their medical records. Enrolled participants will be requested to release copies of their medical records for review by the principal investigator. Study adminsitrators will abstract participant demographics, cancer-related therapies, and clinical outcomes for analysis.
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
- •Adults (≥ 18 years old) with a diagnosis of Stage 3 or Stage 4 cancer (non-hematologic malignancy). Patients with advanced cancers not typically staged 1-4 (such as extensive stage small lung cancer) may be enrolled.
- •Results from Guardant360® test
- •Patient has previously provided contact information (either email or phone) to Guardant Health.
- •Able and wiling to complete the informed consent process.
- •Willingness to consent to the release of medical records.
- •Willingness to provide Medical Records Release
排除标准
- •Unwilling or unable to provide written informed consent.
- •Unable to understand English.
- •Diagnosis of NSCLC
- •Guardant 360® test results released to the patient's physician no less than 14 days and no greater than 60 days prior to initial patient contact.
结局指标
主要结局
Objective response rate (ORR)
时间窗: 3 years
Portion of patients with tumors that are found to have complete or partial response
次要结局
未报告次要终点