Pancreatic Adenocarcinoma
Conditions
Keywords
Pancreatic Adenocarcinoma
Brief summary
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.
Detailed description
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,
Interventions
DIAGNOSTIC_TESTBlood Specimen
Blood samples will be collected from study participants at one time-point in the study, for the following: 1. tumor markers CEA and CA 19-9: 2 ml blood will be collected. 2. glycomics: 0.5 cc blood will be collected 3. ctDNA: 20 cc blood will be collected
Sponsors
National Institutes of Health (NIH)
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incident PDAC during the 3-year study observation period | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timing of incident PDAC occurrence | 3 Years | time from index date to diagnosis |
| Tumor stage at PDAC diagnosis | 3 Years | stage at diagnosis per tumor registry/pathology report |
Countries
United States
Outcome results
None listed