Pancreatic Cancer Early Detection Registry

Identify individuals who are at moderate and high risk or predisposed to developing pancreatic cancer with a familial history in which data collected from this study will be used to identify clinical factors associated with early detection of pancreatic cancer.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Other: hereditary high risk pancreatic cancer

Detailed Description

Pancreatic cancer is the fourth leading cause of cancer death in both men and women in the United States. In 2015, there were 49,000 new diagnoses with 41,000 deaths . A recent analysis of the pedigrees in the National Familial Pancreatic Tumor Registry found that individuals with a family history of pancreatic cancer in first-degree relatives are at an increased risk of developing pancreatic cancer themselves. There are more than a dozen inherited germline mutations that increase the risk of pancreatic cancer in these family members. In an attempt to lower the number of individuals that develop advanced pancreatic cancer, an early-detection program is created to detect tumors at a stage early enough that treatment is likely to be successful. Numerous treatment options exist such as surveillance, radiation therapy, systemic therapy and surgery. Determining which treatment option will be implemented is based on the stage and grade of the tumor/cancer.

• Study Type: Observational
• Enrollment (Actual): 326

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

2. Meet one of the following criteria:

• All affected on the same side of the family (maternal/paternal) unless otherwise specified FDR = first degree relative (parent, sibling, child)
• SDR = second degree relative (e.g., aunt, uncle, grandparent, half-sibling, niece and nephew)

• TDR = third degree relative (e.g., cousin, half-aunt or half-uncle)

  • 1 FDR with pancreatic cancer < age 55

    -≥2 FDR, SDR or TDR with pancreatic cancer at any age

  • Genetic syndrome with pancreatic cancer
  • FDR or SDR with pancreatic cancer at any age and Ashkenazi ancestry

  • FDR or SDR with pancreatic cancer at any age and:

    • 1 relative with ovarian cancer at any age or
    • 1 relative with breast cancer ≤50 or
    • 2 relatives with breast, pancreatic or prostate cancer (Gleason score ≥7) at any age
  • Family history of melanoma OR
  • Has previously had genetic testing and has been determined to have a pathogenic gene variant.
  • FDR with a pathogenic gene variant

Description

Inclusion Criteria:

1. Eligible subjects must be ≥ 18 years of age

2. Meet one of the following criteria:

   • All affected on the same side of the family (maternal/paternal) unless otherwise specified FDR = first degree relative (parent, sibling, child)
   • SDR = second degree relative (e.g., aunt, uncle, grandparent, half-sibling, niece and nephew)

   • TDR = third degree relative (e.g., cousin, half-aunt or half-uncle)

     • 1 FDR with pancreatic cancer < age 55

       -≥2 FDR, SDR or TDR with pancreatic cancer at any age

     • Genetic syndrome with pancreatic cancer
     • FDR or SDR with pancreatic cancer at any age and Ashkenazi ancestry

     • FDR or SDR with pancreatic cancer at any age and:

       • 1 relative with ovarian cancer at any age or
       • 1 relative with breast cancer ≤50 or
       • 2 relatives with breast, pancreatic or prostate cancer (Gleason score ≥7) at any age
     • Family history of melanoma OR
     • Has previously had genetic testing and has been determined to have a pathogenic gene variant.
     • FDR with a pathogenic gene variant

Exclusion Criteria:

1. Prior treatment of pancreatic cancer including radiation therapy, systemic therapy and/or surgery.
2. Current treatment of pancreatic cancer including radiation therapy, systemic therapy and/or surgery.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of imaging for early detection of pancreatic cancer in the high-risk group as defined by inclusion criteria to determine their level of risk and perform surveillance accordingly.	Imaging includes CT/MRI abdomen with and without contrast using the pancreatic protocol, screening for solid pancreatic lesions, atypical cysts and IPMN, pancreatic duct dilatation, pancreas divisum.	Eight years
Evaluation of blood samples for early detection of pancreatic cancer in the high-risk group as defined by inclusion criteria to determine their level of risk and perform surveillance accordingly.		Eight years
Evaluation of endoscopic ultrasound for early detection of pancreatic cancer in the high-risk group as defined by inclusion criteria to determine their level of risk and perform surveillance accordingly		Eight years

Collaborators and Investigators

• Sponsor: Hoag Memorial Hospital Presbyterian
• Investigators: Principal Investigator: Valentina Dalili-Shoaie, MD, Hoag Memorial Hospital Presbyterian

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2016
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Pancreatic Cancer; Hereditary High Risk
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 113-16-CA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No