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

Phase

N/A

Condition

Pancreatic Cancer

Cancer/tumors

Adenocarcinoma

Treatment

Blood Specimen

Clinical Study ID

NCT05287347

21-490

Ages 50-100
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Study population for part 1 of study:

-- Inclusion criteria: i) Male and females age >= 50 years; ii) at least oneclinical visit to an outpatient clinic of the HCO, within the last year, before thestudy 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 thelast year, before the study start date

Exclusion

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.

Study Design

Blood Specimen

January 01, 2022

December 03, 2024

Study 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,"

Connect with a study center

Beth Israel Deaconess Medical Center
Boston, Massachusetts 02115
United States
Site Not Available

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