VERIFI: A Multicenter, Case-Control Clinical Validation Study of the Multiplex Blood Protein Biomarker Test, PancreaSure, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 386
- 试验地点
- 6
- 主要终点
- PancreaSure Sensitivity
研究概览
简要总结
This is a case-control study to clinically validate the performance of PancreaSure, a protein biomarker test, to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control patients not diagnosed with PDAC but at increased risk of disease due to familial/genetic history or clinical symptoms.
详细描述
This is the second case-control study to clinically validate the multi- analyte biomarker diagnostic model, PancreaSure. Serum samples will be collected for analysis from patients with pancreatic ductal adenocarcinoma (PDAC) Stages I and II and non-PDAC controls of similar demographics who were at increased risk of PDAC because of their familial or genetic history. Investigators and patients will not receive individual patient results, therefore patient care will not be impacted by test results. Analysis of blood samples will be conducted in Immunovia's laboratory in Durham, NC by personnel who are blinded to subject data. Biomarker results will be analyzed using a predefined (locked) algorithm with predefined (locked) cut-off resulting in a positive/negative test outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent available
- •> 45 years of age
- •PDAC cases
- •Treatment-naïve, pathologically confirmed PDAC Stage I or Stage II
- •Sporadic or familial/genetic PDAC
- •Individuals at high risk for PDAC because of their familial and/or genetic history
- •Individuals at high risk for PDAC because of pancreatic cysts between 1.0cm and 3.0cm in diameter.
- •Controls will be selected to have similar demographic features (age/gender) to PDAC patients
排除标准
- •Prior treatment for PDAC (i.e., prior resection, radiotherapy, or chemotherapy)
- •Current immunosuppressive (e.g., systemic steroid therapy) or chemotherapy
- •Major surgery or significant trauma within 12 weeks prior to blood sample collection
- •Non-PDAC malignancies within 3 years prior to sample collection squamous or basal cell skin carcinoma is not an exclusion criteria)
- •Control patients who currently have
- •biliary obstruction secondary to gallstones
- •prior diagnosis or imaging evidence of chronic pancreatitis
- •cystic pancreatic lesions >3.0 cm in diameter or showing worrisome features according to Fukuoka Consensus Guidelines.
结局指标
主要结局
PancreaSure Sensitivity
时间窗: Baseline
Determine the sensitivity of PancreaSure in the classification of serum samples from patients diagnosed with PDAC as positive for PDAC, in a study sample containing both PDAC and control samples.
次要结局
- PancreaSure Specificity(Baseline)
- Performance versus CA19-9 alone(Baseline)