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

Pancreatic Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05287347
• Other study ID #: 21-490
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

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