Clinical trial NCT05287347: Panc CA Risk Model & Biomarker Testing In High-Risk Cohort
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pancreatic Adenocarcinoma
Keywords: Pancreatic Adenocarcinoma
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Dana-Farber Cancer Institute
First posted: 2022-03-18
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
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

Brief 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.

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,"

Eligibility criteria: 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.

Primary outcomes:
measure: Incident PDAC during the 3-year study observation period
timeFrame: 3 Years
Secondary outcomes:
measure: Timing of incident PDAC occurrence
timeFrame: 3 Years
measure: Tumor stage at PDAC diagnosis
timeFrame: 3 Years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Limor Appelbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: