Multicenter, Case-Control Clinical Validation Study of a Multiplex Blood Protein Biomarker Test, IMMNOV-2, 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
- 1,066
- 试验地点
- 15
- 主要终点
- Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls.
研究概览
简要总结
This is a case-control study to clinically validate the performance of 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 case-control study is being conducted to determine the performance of a multiplex protein biomarker model in human serum samples.
Serum samples were collected for analysis from patients with Stages I and II pancreatic ductal adenocarcinoma (PDAC) and non-PDAC controls of similar demographics who were at increased risk of PDAC because their familial or genetic history or clinical symptoms. 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 three predefined (locked) algorithm with predefined (locked) cut-offs 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
- 是
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 with clinical symptoms/signs (e.g. abnormal imaging of the pancreas such as fullness, unexplained weight loss, etc) suggestive of PDAC who were found to NOT have PDAC based on clinical investigation (imaging evidence within 6 months of blood draw)
- •Controls will be selected to have similar demographic features (age/gender) to PDAC patients, as possible.
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
Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls.
时间窗: Baseline
次要结局
- Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in the overall population(Baseline)
- Sensitivity and specificity of IMMNOV-2 in patients age > or equal to 65 years of age(Baseline)
- Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in patients age > or equal to 65 years old(Baseline)