Prospective Multicenter Observational Study for Validation of a Pancreatic Cancer Risk Model and Assessment of the Predictive Value of Blood Biomarkers in a High-risk Cohort
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Incident PDAC during the 3-year study observation period
研究概览
简要总结
The purpose of this study is to test a double screening strategy for pancreatic cancer, based on a model developed using patient medical records. Investigators would also like to test whether adding specific blood tests, can further help identify people who have a higher risk of pancreatic cancer than the general population, and would benefit from imaging in order to detect cancer early.
详细描述
This research aims to identify people who have a higher risk of pancreatic cancer than the general population, by testing a double-screening strategy for pancreatic cancer. The purpose is to allow early detection of cancer, which potentially leads to cure.
The double-screening will include a computer-based model developed using clinical data from medical records, and three different blood tests for early detection of pancreatic cancer.
Participation in this study involves having medical records followed up for up to three years, and a single donation of blood specimens.
- This is a Combined Retrospective and Prospective Review:
- The first part of the study, involves collection of retrospective data from Electronic Health Record database (for the 3 collaborating HCOs) in order to deploy our EHR model, so that a high-risk group for pancreatic cancer can be identified. All individuals stratified into low, intermediate or high risk groups by the model, will be prospectively, electronically followed to assess outcome.
- The second stage is prospective, and involves requesting biological specimen donations from participants identified as high-risk, for biomarker testing. The prospective "observation period" is up to 3 years (depending on each subject's index date at retrospective recruitment and outcome). Biological specimens will be collected during the prospective "observation period,"
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Study population for part 1 of study:
- •- Inclusion criteria: i) Male and females age >= 50 years; ii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date.
- •Study population for part 2 of study:
- •i) model-assigned high-risk subjects; ii) Male and females age >= 50 years; iii) at least one clinical visit to an outpatient clinic of the HCO, within the last year, before the study start date
排除标准
- •Exclusion Criteria for part 1 of study:
- •Personal history of PDAC or current PDAC
- •Age below
- •Exclusion Criteria for part 2 of study
- •model-assigned low or intermediate risk subjects
- •Personal history of PDAC or current PDAC
- •Age below 50.
结局指标
主要结局
Incident PDAC during the 3-year study observation period
时间窗: 3 Years
The diagnosis of PDAC will be determined by ICD code (ICD10 codes C25.X, excluding C25.4), tumor registry records or pathology reports
次要结局
- Tumor stage at PDAC diagnosis(3 Years)
- Timing of incident PDAC occurrence(3 Years)
研究者
Limor Appelbaum
Principal Investigator
Beth Israel Deaconess Medical Center