NCT05287347

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Accepted

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,"

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood 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

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-03
• Completion: 2024-12-03
• First posted: 2022-03-18
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States