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

• Sponsor: Dana-Farber Cancer Institute (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05287347
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 4,000
• Location: 1
• Anticipated Duration (Months): 45
• Patients Per Site Per Month: 88.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Adenocarcinoma	Diagnostic Test: Blood Specimen

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,"

Study Design

• Study Type: Observational
• Anticipated Enrollment: 4000 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Mar 31, 2025
• Anticipated Study Completion Date: Mar 31, 2026

Arms and Interventions

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; 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

Outcome Measures

Primary Outcome Measures

1. Incident PDAC during the 3-year study observation period [3 Years]

   The diagnosis of PDAC will be determined by ICD code (ICD10 codes C25.X, excluding C25.4), tumor registry records or pathology reports

Secondary Outcome Measures

1. Timing of incident PDAC occurrence [3 Years]

   time from index date to diagnosis

2. Tumor stage at PDAC diagnosis [3 Years]

   stage at diagnosis per tumor registry/pathology report

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

• 1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Dana-Farber Cancer Institute
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Limor Appelbaum, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Limor Appelbaum, MD, Principal Investigator, Dana-Farber Cancer Institute
• ClinicalTrials.gov Identifier: NCT05287347
• Other Study ID Numbers: 21-490
• First Posted: Mar 18, 2022
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Limor Appelbaum, MD, Principal Investigator, Dana-Farber Cancer Institute: Pancreatic Adenocarcinoma
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Mar 31, 2022