Feasibility and Accuracy of Nanosensor-based Cancer Diagnosis at the Point-of-care (Chedza)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Time to diagnosis
研究概览
简要总结
Prospective feasibility and validation study of a novel, near-to-care modality for diagnosis of malignancy among cancer suspects.
详细描述
Prospective feasibility and validation study of a novel contrast microhalography (CEM) device for diagnosis of malignancy in Botswana. Consenting patients identified by their providers as requiring a fine needle aspirate (FNA) or percutaneous biopsy for assessment for possible lymphoma or breast cancer will undergo standard diagnostic procedure. Concurrently these patients will have additional FNA fluid tested using the portable novel nanosensor-based device (CEM). Diagnosis made from standard anatomic pathology, flow cytometry, and/or cytology will be compared with the diagnosis made using the CEM platform. Assessment of the feasibility and acceptability of the CEM platform will be performed. Assessment of training requirements for CEM platform will be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking, open label.
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
- •Botswana citizen
- •Age 18 years or older
- •Able and willing to provide informed consent
- •Undergoing diagnostic procedure for palpable abnormality (biopsy, node/mass resection, or fine-needle aspirate) for diagnosis of possible lymphoid malignancy or breast cancer
排除标准
- •Involuntary incarceration (prison, jail, etc.)
- •Procedures involving internal organs or locations expected to have elevated risk of complication
- •Increased risk for severe bleeding as defined as known hemophilia or other bleeding disorder, use of anticoagulants in past week (not including aspirin or other NSAIDS), advanced liver disease, or other condition determined by clinician to significantly increase bleeding risk of procedure
- •Known pregnancy
- •Critical illness as defined by current intensive care admission, hypotension (systolic BP<100mmHg), hypoxemia (O2 saturation <94% on room air), or other condition determined by clinician to significantly decrease physiologic tolerance of procedure
- •Other condition felt by the clinician performing procedure to significantly increase risk of procedure
结局指标
主要结局
Time to diagnosis
时间窗: Day 1, at time of diagnosis
Time from diagnostic procedure to knowledge of test result by the treating clinician
Accuracy for diagnosis of invasive breast cancer
时间窗: Day 1, at time of diagnosis
Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.
Proficiency in testing using CEM platform
时间窗: Day 1, At completion of training
Proportion of personnel of varying laboratory experience and training modalities with proficiency using CEM platform
Accuracy for diagnosis of non-Hodgkin lymphoma
时间窗: Day 1, at time of diagnosis
Accuracy (proportion of true positive and true negative out of total number assessed) of CEM in comparison with standard diagnostic approach.
次要结局
- Accuracy for molecular subtype diagnosis of invasive breast cancer(Day 1, at time of diagnosis)
- Accuracy for sub-type diagnosis (aggressive vs. indolent) of non-Hodgkin lymphoma(Day 1, at time of diagnosis)
研究者
Scott Dryden-Peterson
Research Associate
Harvard School of Public Health (HSPH)