A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 103
- 试验地点
- 7
- 主要终点
- The proportion of patients with benign disease who underwent invasive diagnostic procedures.
研究概览
简要总结
This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial.
详细描述
Objectives:
- To obtain the combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score in a prospective observational trial and estimate potential clinical utility compared to the Mayo Model.
- To establish standard operating procedures (SOPs) and protocols in a prospective observational trial in anticipation of a future randomized control trial. These include the REDCAP data input protocols, the radiomic protocols, blood draws in the CLIA environment, and estimating the CBM score in a time reasonable for clinical practice (< 2 weeks).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults > 21 y/o
- •IPNs 8-30mm referred for evaluation Figure
- •AUC and reclassification of Combined Biomarker Model
- •Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model
- •Solid nodules or part-solid nodules with solid component >=8mm
- •CT scan with nodule of concern performed within 60 days of enrollment
排除标准
- •Pure ground glass nodule or subsolid nodule with solid component <8mm
- •Currently on therapy for any cancer
- •History of primary lung cancer within the last 5 years
- •Multiple nodules highly suspicious for metastatic disease
- •Other malignancy within the last 2 year - Excluding skin cancer other than melanoma
- •Pregnant women
- •Prisoners
- •Inability to provide informed consent
- •Serologic evidence of active fungal infection
研究组 & 干预措施
Indeterminate Pulmonary Nodules
A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model.
干预措施: Blood collection (Procedure)
Indeterminate Pulmonary Nodules
A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model.
干预措施: Chest Computed Tomography (Procedure)
结局指标
主要结局
The proportion of patients with benign disease who underwent invasive diagnostic procedures.
时间窗: Up to approximately 2 years
Measure time needed to provide the CBM Value to clinician
时间窗: Up to approximately 2 years
Number of days
Measure time needed to obtain hs CYFRA 21-1 values
时间窗: Up to approximately 2 years
Number of hours (days)
Measure time needed to perform radiomics
时间窗: Up to approximately 2 years
Number of hours (days)
The time to diagnosis (in days) for patients with cancer.
时间窗: Up to approximately 2 years
次要结局
未报告次要终点
研究者
Eric Grogan
Professor of Thoracic Surgery & Medicine
Vanderbilt-Ingram Cancer Center