CONQUER Cancer Study: To Collect Blood Samples From Cancer and Non-cancer Participants for Development and Validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- To differentiate lung cancer signals from non-cancer signals based on analysis of OncoSweep Lung Spotlight.
研究概览
简要总结
CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line'
详细描述
OncoSweep Cancer Spotlight and Spectrum Product Lines are qualitative in vitro diagnostic devices testing plasma specimens for detecting circulating miRNA expression, ctDNA methylation status, platelet RNA analysis, and tumor marker expressions by utilizing real-time polymerase chain reaction (qPCR) and next-generation sequencing (NGS). This is a two-arm, open-label, non-randomized controlled pilot study intends to screen adults 18 years or older, who are treatment-naïve for cancers and have pulmonary nodules or mass detected by low-dose computerized tomography (LDCT) or standard computerized tomography (CT) scans. OncoSweep Lung Spotlight will be utilized with venous blood samples collected in the healthcare facility where the study is being conducted. The X-ray, LDCT/ standard CT scan, blood laboratory test data, or biopsy results will be collected from the control group, and the blood sample will be analyzed by OncoSweep Lung Spotlight. Results generated from both groups will be evaluated against each other. The result of OncoSweep Lung Spotlight provides additional evidence to support or assist medical diagnoses when used in combination with LDCT/ standard CT scan data.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion
- •Individual who is not mentally impaired, capable to read, understand, and is willing to provide signed and dated informed consent form.
- •Individual is aged 18 years old or above.
- •Individual who is willing to provide information on the given questionnaire. Test group: Individual was diagnosed with pulmonary nodules or masses by low-dose CT (LDCT)/ CT, and evaluated by the physician needed to conduct a biopsy or/ and surgery has been arranged.
- •Control group: Individual is willing to undergo LDCT or CT scan with 3-5 mm spatial z-axis resolution, pulmonary function examination, X-ray, laboratory blood test, and blood drawing.
- •Control group: Individual has no abnormal finding from LDCT or CT scan with 3-5 mm spatial z-axis resolution and pulmonary function examination(FEV1/FVC Ratio≧70%).
- •Individual did not donate blood or receive blood transfusion within two months before joining the study.
排除标准
- •Exclusion
- •Individual who is not suitable for participating as per Investigator's judgement.
- •Individual who has undergone gene therapy or related product within one year prior to enrolling in this study.
- •Individual who is attending another clinical study at the time of enrollment.
- •Individual who is known to be pregnant.
- •Individual who has received a vaccine within two weeks.
- •Individual who has a history of any cancer occurrences other than lung cancer.
结局指标
主要结局
To differentiate lung cancer signals from non-cancer signals based on analysis of OncoSweep Lung Spotlight.
时间窗: two years
To compare blood samples from lung cancer cases and non-cancer control subjects to develop and evaluate:1.Cancer models for discriminating lung cancer versus non-cancer 2.Platform evaluation 3.Data storage and algorithm establishment for further cancer research
次要结局
未报告次要终点