2024-10
2026-10-31
2027-10-31
4000
NCT05287347
Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
OBSERVATIONAL
Panc CA Risk Model & Biomarker Testing In 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.
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,"
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-03-10 | N/A | 2024-03-27 |
2022-03-10 | N/A | 2024-03-28 |
2022-03-18 | N/A | 2024-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | 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
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Limor Appelbaum, MD Phone Number: 617) 667-2345 Email: lappelb1@bidmc.harvard.edu |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
50 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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