Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 409
- 试验地点
- 35
- 主要终点
- Blood-based biomarkers associated with genetic and epigenetic alterations.
研究概览
简要总结
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens to evaluate biomarkers associated with cancer for diagnostic assay development.
详细描述
Subjects will have been recently diagnosed with an untreated hematologic malignancy. Subjects will have a blood sample collected at enrollment and provide medical history prior to initiation of treatment. There will be no further follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Subject is male or female ≥ 18 years of age.
- •Subject has an untreated hematologic malignancy.
- •Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.
排除标准
- •Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
- •Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
- •Any treatment for the primary malignancy. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment prior to blood sample collection.
- •Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
- •Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
- •IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
结局指标
主要结局
Blood-based biomarkers associated with genetic and epigenetic alterations.
时间窗: Point in time blood collection (1 day) at enrollment
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with a hematologic malignancy at the pre-intervention stage.
次要结局
未报告次要终点