Pancreatic Cancer Screening for At-risk Individuals — PancreasScan  

Pancreatic Cancer, Adult Clinical Trial

Official title: Pancreatic Cancer Screening for At-risk Individuals (The Pancreas Scan Study)

Status Recruiting

Clinical Trial Summary

The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of screening of pancreas cancer in individuals who are at-risk for pancreatic cancer. We plan to use International Cancer of the Pancreas Screening (CAPS3) Consortium recommendations to standardize study population, screening methodology, and study outcomes.

Clinical Trial Description

Methods The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of pancreas cancer screening in high-risk individuals. High-risk patients who are undergoing pancreatic cancer screening in accordance with national guidelines at participating study centers will be eligible for the study. Information regarding patient characteristics, findings at screening examination, and patient outcomes will be collected.

Primary Outcome (Primary Aim):

To identify the proportion of patients who meet International Cancer of the Pancreas Screening Consortium screening criteria 3rd update (CAPS Jan 2020), or more updated national guidelines, who are found at the screening to have high-risk pancreatic lesions amenable to treatment (definition of "high-risk lesions amenable to treatment" is provided under the section on study outcomes).

Secondary outcomes (Secondary Aims) will include (details are provided under the section on study outcomes):

1. Proportion of patients diagnosed with any stage pancreatic cancer

2. proportion of patients undergoing pancreatic surgery

3. Cancer-related outcome, defined as a cancer-related death

4. proportion of patients experience harms, defined as any complications/adverse event due to screen related procedures

5. Comparison of cancer outcome, defined cancer-related death, in screen-detected cancer with cancer outcomes reported by the SEERs population-based registry. Study overview Study type: a prospective observational cohort High-risk patients who meet study inclusion criteria at study centers will be identified.

Screening and patient follow-up will be performed at individual study centers per standard clinical practice. Patient characteristics, screening performed and screening results, clinical outcome data will be collected by individual study centers. This data will be stored and analyzed at central study REDCap located at Beth Israel Deaconess Medical Center (BIDMC) ;

Related Conditions & MeSH terms

• Pancreatic Cancer, Adult
• Pancreatic Neoplasms

• NCT number: NCT05006131
• Study type: Observational
• Source: Beth Israel Deaconess Medical Center
• Contact: Roya Dastjerdi, MD
• Phone: 617-667-4046
• Email: rdastjer@bidmc.harvard.edu
• Status: Recruiting
• Start date: July 10, 2020
• Completion date: March 10, 2028