NCT05516927已完成不适用
The Sanderson Study: A Diagnostic Case-Control Study for the Development of Multiomics Blood Tests for Cancer Screening in a Real World Setting
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 788
- 试验地点
- 23
- 主要终点
- Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants
研究概览
简要总结
This protocol is a prospective, case-control multi-center diagnostic study to assess the sensitivity and specificity of blood-based screening tests for the early detection of multiple cancers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥30 years within 30 days of enrollment
- •Able and willing to provide blood samples per protocol
- •Able to comprehend and willing to sign and date the informed consent and HIPAA
- •Authorization documents
- •Able and willing to allow existing health data to be utilized for study purposes
排除标准
- •Any history of solid organ or bone marrow transplantation
- •Any physical trauma or surgery requiring inpatient overnight hospitalization in the 30 days preceding enrollment
- •Received a blood transfusion in the 30 days preceding enrollment
- •A medical condition that, in the opinion of the Investigator, should preclude enrollment in the study
- •Known to be pregnant
- •Any therapy for cancer, including but not limited to surgery, chemotherapy, biologic therapy, immunotherapy, and/or radiation therapy in the 5 years preceding enrollment
- •Participated or currently participating in a clinical research study in which an experimental medication has been administered during the 30 days preceding enrollment
- •Participated or currently participating in another Freenome-sponsored clinical study
- •For non-cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe
- •For the cancer groups: Any previous cancer diagnosis in the 5 years preceding enrollment, apart from the current cancer diagnosis; OR recurrence of the same primary cancer within any timeframe; OR concurrent diagnosis of multiple primary cancers within any timeframe
结局指标
主要结局
Comparison of Blood Samples from Cancer Case and Non-cancer Control Participants
时间窗: 12 months
To compare blood samples from cancer case and non-cancer control subjects in order to develop and characterize blood-based multiomics tests in specific cancer types or in a combination of multiple cancers.
次要结局
未报告次要终点
研究者
研究点 (23)
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