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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05287347
Other study ID # 21-490
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 2024
Est. completion date October 31, 2027

Study information

Verified date March 2024
Source Beth Israel Deaconess Medical Center
Contact Limor Appelbaum, MD
Phone 617) 667-2345
Email lappelb1@bidmc.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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,"


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 4000
Est. completion date October 31, 2027
Est. primary completion date October 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 100 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Dana-Farber Cancer Institute, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Timing of incident PDAC occurrence time from index date to diagnosis 3 Years
Secondary Tumor stage at PDAC diagnosis stage at diagnosis per tumor registry/pathology report 3 Years
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