NCT03662204已完成不适用
Blood Sample Collection to Evaluate Biomarkers in Subjects With Untreated Solid Tumors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,133
- 试验地点
- 119
- 主要终点
- Biomarker Evaluation
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 who have been diagnosed, or who have a suspicion of diagnosis based on imaging, with any solid tumor. 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 primary malignancy of breast, lung, colorectal, prostate, bladder, uterine, kidney/renal pelvis, pancreatic, liver, stomach, ovarian or esophageal cancer.
- •Subject has suspicion of a primary malignancy of pancreatic, bladder, kidney/renal pelvis, or ovarian cancer based on imaging.
- •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
- •Prior or concurrent cancer diagnosis defined as:
- •Any previous cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers); OR
- •Recurrence of the same primary cancer within any timeframe; OR
- •Concurrent diagnosis of multiple primary cancers
- •Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
- •Any treatment for the primary malignancy or sites of metastases. Subject may not have started neo-adjuvant chemotherapy, neo-adjuvant radiation therapy, immunotherapy or other treatment and/or surgery 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
Biomarker Evaluation
时间窗: Point in time (one day) blood collection at enrollment
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with solid tumor cancers.
次要结局
未报告次要终点
研究者
研究点 (119)
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