Panc CA Risk Model & Biomarker Testing In High-Risk Cohort

Study Overview
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Brief Summary
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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
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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,

Official Title
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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

Conditions
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Pancreatic Adenocarcinoma

Intervention / Treatment
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* Diagnostic Test: Blood Specimen


Participation Criteria
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Eligibility Criteria
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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: Exclusion Criteria for part 1 of study: Personal history of PDAC or current PDAC Age below 50. Exclusion Criteria for part 2 of study model-assigned low or intermediate risk subjects Personal history of PDAC or current PDAC Age below 50.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective<br>Blood specimens will be obtained for the model-assigned high risk cohort at each collaborating HCO, over two years of recruitment period. Data of each participant will be electronically followed for observation of outcome measures for up to 3 years. | Diagnostic Test: Blood Specimen<br>* Blood samples will be collected from study participants at one time-point in the study, for the following: tumor markers CEA and CA 19-9: 2 ml blood will be collected. glycomics: 0.5 cc blood will be collected ctDNA: 20 cc blood will be collected<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident PDAC during the 3-year study observation period | The diagnosis of PDAC will be determined by ICD code (ICD10 codes C25.X, excluding C25.4), tumor registry records or pathology reports | 3 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of incident PDAC occurrence | time from index date to diagnosis | 3 Years | 
| Tumor stage at PDAC diagnosis | stage at diagnosis per tumor registry/pathology report | 3 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Adenocarcinoma