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

NCT05287347 | Withdrawn

• 1 other identifier: 21-490
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Timing of incident PDAC occurrence

  3 Years

• Tumor stage at PDAC diagnosis

  3 Years

Study Arms (1)

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

Interventions

Blood Specimen DIAGNOSTIC_TEST

Blood samples will be collected from study participants at one time-point in the study, for the following: 1. tumor markers CEA and CA 19-9: 2 ml blood will be collected. 2. glycomics: 0.5 cc blood will be collected 3. ctDNA: 20 cc blood will be collected

Prospective

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Study population for part 1 of study:
• 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

You may not qualify if:

• Personal history of PDAC or current PDAC
• Age below 50.
• model-assigned low or intermediate risk subjects
• Personal history of PDAC or current PDAC
• Age below 50.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institutes of Health (NIH): collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Specimen collection: 1. Tumor markers CEA, CA 19-9: 2 ml blood for will be collected in a serum separator tube, processed at each institution and serum stored locally in -80C freezers. Samples will be shipped in batches every 2 months to BIDMC for tumor marker analysis, and results recorded and blinded until the end of the study collection period. 2. Serum glycomics: 0.5 cc of blood will be collected in sterile Vacutainer tubes. Serum will be separated and aliquoted in 50 microliters aliquots, and frozen at -80C, for up to 3 years. 3. ctDNA, 20 cc of blood will be collected from patients in specialized tubes to stabilize the leukocytes and avoid contamination by genomic DNA. Samples will be processed within 48 hours to separate plasma, which will be frozen for batch analysis.

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Limor Appelbaum, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: January 1, 2022
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (1)