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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
5,000
Carbohydrate antigen (CA) 19-9, and Hemoglobin A1C (HbA1c) per standard-of-care.
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Brigham and Women's Hospital
Boston, Massachusetts, United States
NOT_YET_RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGNumber 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
Positive Predictive Value of Blood Assays
Positive predictive value of blood assays, defined as 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 a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a positive blood assay.
Time frame: 6-monthly for 3 years
Negative Predictive Value of Blood Assays
Negative predictive value of blood assays, defined as CA19-9 (\<=35U/mL or \<20% increase) or diabetes (FBG \<100mg/dL for first time or HgbA1c increased by less than 0.5) assay result or ENDPAC score \<3, without a positive biopsy for PDAC or High-Grade Dysplasia within six months divided by the total number with a negative blood assay.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Annually and per National Comprehensive Cancer Network Guidelines (NCCN) guidelines.
Time frame: 6-monthly for 3 years
Proportion of Screen-Detected, Resected Pancreatic Lesions
Number of screen-detected pancreatic lesions that are resected compared to the total number of screen-detected pancreatic lesions.
Time frame: 6-monthly for 3 years
Proportion of Non-Worrisome Pancreatic Lesions
Number of pancreatic lesions that are biopsied without cancer or high-grade dysplasia divided by number of pancreatic lesions that are biopsied.
Time frame: 6-monthly for 3 years
Incremental Yield of Blood-Based Assays over Standard-of-Care Screening
Number of imaging-negative, assay-positive cases showing cancer or high-grade dysplasia divided by the total number of imaging-negative cases with cancer or high-grade dysplasia.
Time frame: 6-monthly for 3 years
Number of False-Positive Assay Results
Number of positive assay results, defined as 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, without a clinical diagnosis of pancreatic cancer within one year.
Time frame: 6-monthly for 3 years
Number of Non-PDAC Cancer Diagnoses
Number of non-PDAC cancer detected through blood-based assays, EUS and/or MRI during the active screening period.
Time frame: 6-monthly for 3 years
Clinical Predictors of Neoplastic Development
Frequencies of clinical predictors of neoplastic development as indicated by responses to the study surveys.
Time frame: up to 8 years