Prospective Screening for Pancreatic Ductal Adenocarcinoma in High-Risk Individuals
Summary
The purpose of this research is to see if adding blood-based tests and symptom review to standard-of-care pancreatic cancer screening procedures can identify cancer early among individuals with increased risk.
Detailed description
In this research study, investigators will combine blood-based tests and review of symptoms with standard-of-care pancreatic cancer screening procedures to see if pancreatic cancer can be detected early among individuals with increased risk. Pancreatic cancer screening procedures include Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI), or Magnetic Resonance Cholangiopancreatography (MRCP). The research study procedures include screening for eligibility, questionnaires, clinic visits, endoscopic ultrasound (EUS) or Magnetic Resonance (MRI)/Magnetic Resonance Cholangiopancreatography (MRCP), and collection of blood, stool, and saliva samples. Participation in this research study will be a minimum of 30 months and up to 20 years via review of medical records and the annual collection of blood and stool samples. It is expected that about 5,000 people will take part in this research study. This study is supported by the Hale Family Research Center at Dana-Farber Cancer Institute.
Arms & interventions
- OtherScreening Blood Tests
Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.
- Diagnostic TestEndoscopic Ultrasound
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
- Combination ProductMagnetic Resonance Imaging
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
- Combination ProductMagnetic Resonance Cholangiopancreatography
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Outcome measures
Primary
Number of Incident Pancreatic Cancers or High-Grade Pancreatic Neoplasms
Subjects will be counted in this metric if they have pathological tissue confirmation of a pancreatic cancer or high-grade dysplasia during each observation period.
Time frame: 6-monthly for 3 years with 5-year follow-up
Number of Imaging-Positive Pancreatic Cancers or High-Grade Neoplasms
Subjects will be considered imaging-positive if they have a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia that was initially detected on standard-of-care screening MRI or EUS during each observation period.
Time frame: 6-monthly for 3 years with 5-year follow-up
Number of Imaging-Negative, Assay-Positive Pancreatic Cancers or High-Grade Neoplasms
Subjects will be considered imaging-negative and assay-positive if: 1) the subject has a study visit that yields any newly positive CA19-9 (\>35U/mL or \>=20% increase) or diabetes (FBG \>100mg/dL for first time or HgbA1c increased by 0.5) assay result or ENDPAC score \>=3 with negative MRI and/or EUS at that visit or within six months prior to that visit; and 2) has a biopsy-confirmed pancreatic ductal adenocarcinoma or high-grade dysplasia within two years after that visit.
Time frame: 6-monthly for 3 years with 5-year follow-up
Secondary
Positive Predictive Value of Blood Assays
Time frame: 6-monthly for 3 years
Negative Predictive Value of Blood Assays
Time frame: 6-monthly for 3 years
Proportion of Screen-Detected, Resected Pancreatic Lesions
Time frame: 6-monthly for 3 years
Proportion of Non-Worrisome Pancreatic Lesions
Time frame: 6-monthly for 3 years
Incremental Yield of Blood-Based Assays over Standard-of-Care Screening
Time frame: 6-monthly for 3 years
Number of False-Positive Assay Results
Time frame: 6-monthly for 3 years
Number of Non-PDAC Cancer Diagnoses
Time frame: 6-monthly for 3 years
Clinical Predictors of Neoplastic Development
Time frame: up to 8 years
Eligibility criteria
Study locations (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana Farber Cancer Institute
Boston, Massachusetts, 02215