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

Beth Israel Deaconess Medical Center

Overview

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.

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,"

Study Type

OBSERVATIONAL

Conditions

Pancreatic Adenocarcinoma

Interventions

Blood SpecimenDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 50 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: 3 Years

Secondary Outcomes

Timing of incident PDAC occurrence

time from index date to diagnosis

Time frame: 3 Years

Tumor stage at PDAC diagnosis

stage at diagnosis per tumor registry/pathology report

Time frame: 3 Years

Data from ClinicalTrials.gov

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