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Pancreatic Cancer Early Detection Registry


2016-10-18


2023-07-27


2023-07-27


326

Study Overview

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.

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.

  • Pancreatic Cancer
  • OTHER: hereditary high risk pancreatic cancer
  • 113-16-CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-08-22  

N/A  

2024-10-09  

2022-08-26  

N/A  

2024-10-15  

2022-08-29  

N/A  

2024-10  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime 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 accordinglyEight years
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Valentina Dalili-Shoaie, MD, Hoag Memorial Hospital Presbyterian

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available