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

Beth Israel Lahey Health

Status: Withdrawn

Conditions: Pancreatic Adenocarcinoma

Treatments: Diagnostic Test: Blood Specimen

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05287347

21-490

Details and patient eligibility

About

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.

Full 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,"

Sex: All

Ages: 50 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

0 participants in 1 patient group

Prospective

Description:

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.

Treatment:

Diagnostic Test: Blood Specimen