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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pancreatic Adenocarcinoma
• Intervention / Treatment: Diagnostic test: Blood Specimen

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,"

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Blood Specimen; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Dana-Farber Cancer Institute; National Institutes of Health (NIH)
• Investigators: Principal Investigator: Limor Appelbaum, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 3, 2024
• Study Completion (Actual): December 3, 2024

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Pancreatic Adenocarcinoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma
• Other Study ID Numbers: 21-490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No