Lack of funding

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,"

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 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

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.

Data can be shared no earlier than 1 year following the date of publication

Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu