Pancreatic Cancer Screening for At-risk Individuals
ConditionPancreatic Cancer, Adult
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorBeth Israel Deaconess Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inclusion criteria 1-3 are indications for pancreatic cancer screening as defined by the CAPS3 guidelines or updated national pancreatic cancer screening guidelines. Patients who do not meet these guidelines but are undergoing pancreatic cancer screening at the discretion of their treating physician at participating study centers will also be included in the study. Based upon the indication for screening, patients will be categorized as either meeting CAPS3 screening criteria, or not meeting CAPS3 screening criteria.
Familial Pancreatic cancer kindred. This is defined as family history of pancreas cancer that meet the criteria listed below.
If at least two affected relatives who are First degree relatives (FDR) to each other, of whom at least one is an FDR to the individual considered for surveillance
If at least three affected relatives on the same side of the family, of whom at least one is an FDR to the individual considered for surveillance
Disqualifiers
Patients presenting with symptoms suggestive of pancreatic cancer who are undergoing diagnostic EUS or MRCP e.g. acute recurrent pancreatitis, abnormal imaging
Trial population
Any patient who meets the eligibility criteria exposed above based on CAPS3 or updated national pancreatic screening guidelines criteria at BIDMC and collaboration centers part of the study in the time frame of 2020 to 2027 (which is the end of enrollment)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Screening for pancreatic cancer
Other interventionScreening for pancreatic cancer using EUS or MRI
Treatment groups
1,395 Participants
are divided into 1 treatment groupGroup A: Patients who are at high-risk for pancreatic cancer1 intervention
Trial outcomes
Primary outcomes
1
Proportion of screening patients found to have high-risk pancreatic lesions amenable to treatment
Proportion of patients who meet CAPS 3 or updated national screening guidelines criteria who are found at screening to have high-risk pancreatic lesions amenable to treatment. These are defined as the following: 1. Lesions with high-grade dysplasia (HGD) 2. High-grade pancreatic intraepithelial neoplasia (PanIN) 3. Resectable or borderline resectable pancreatic cancer. Pancreatic cancers that were staged T1-3, N0-2, and M0 designated as resectable or borderline resectable. Cancers that were staged as T4 or M1 were considered locally advanced or metastatic and therefore designated as unresectable 4. Main duct intra-ductal papillary mucinous neoplasm (IPMN).This will be defined per Fukuoko guidelines as dilation of main pancreatic duct ≥ 5 mm, after duct dilation due to other causes have been excluded. 5. Branch-duct IPMN with "worrisome features". 6. Neuroendocrine tumor ≥ 2 cm.
Time frame
From year 1 to year 12 (until the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team.Secondary outcomes
1
Proportion of screening patients found to have high-risk pancreatic lesions
Proportion of patients who meet CAPS screening eligibility criteria, who are found at screening to have high-risk pancreatic lesions amenable to treatment
Time frame
From year 1 screening to year 12 (end of at least 5 years follow up in 2032) screening (annually)2
Proportion of screening patients found to have low or moderate-risk pancreatic lesions by screening
Proportion of patients undergoing pancreatic cancer screening who are found to have low or moderate-risk pancreatic lesions. Low or moderate-risk pancreatic lesions pancreatic lesions are defined as: 1. Branch-duct IPMN without HGD 2. Neuroendocrine tumor \< 2 cm 3. dilation of main pancreatic duct \< 8 mm 4. Chronic pancreatitis-like change
Time frame
From year 1 to year 12 (end of at least 5 years follow up in 2032) according to the standard of care designated by GI team.3
Proportion of patients undergoing screening who undergo pancreatic surgery
Proportion of patients who undergo pancreatic surgery as a result of screening test results following the Fukuoka revised guidelines for the management for high-risk lesions or surgical treatment designated by interdisciplinary medical team
Time frame
From year 1 to year 12, which is the end of at least 5 years follow up in 2032.(throughout the duration of the study)4
Proportion of "low yield" pancreatic surgeries performed in screening patients
Proportion of patients who undergo "low-yield pancreatic surgery" as a result of screening test results. Low yield pancreatic surgery is defined surgery where surgical pathology does not yield high-risk pancreatic lesions. See primary outcome for definition of high-risk pancreatic lesions.
Time frame
From year 1 to year 12, which is the end of at least 5 years follow up in 2032.(throughout the duration of the study)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Beth Israel Deaconess Medical Center
Lead sponsor
Washington University School of Medicine
Collaborator
Zucker School of Medicine at Hofstra/Northwell
Collaborator
Rush University Medical Center
Collaborator
Wake Forest University
Collaborator
University of Arkansas
Collaborator
Source ClinicalTrials.gov