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

NCT ID: NCT05287347

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-12-03

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,"

Conditions

Pancreatic Adenocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Prospective

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.

Blood Specimen

Intervention Type: DIAGNOSTIC_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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Study population for part 1 of study:

• 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

• Personal history of PDAC or current PDAC
• Age below 50.

• model-assigned low or intermediate risk subjects
• Personal history of PDAC or current PDAC
• Age below 50.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Limor Appelbaum

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Limor Appelbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

21-490

Identifier Type: -

Identifier Source: org_study_id