Pancreatic Cancer Screening for At-risk Individuals (PancreasScan)
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|ClinicalTrials.gov Identifier: NCT05006131|
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : August 16, 2021
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer, Adult||Other: Screening for pancreatic cancer|
Methods The investigators' goal is to conduct a prospective multicenter study to evaluate the yield and outcomes of pancreas cancer screening in high-risk individuals. High-risk patients who are undergoing pancreatic cancer screening in accordance with national guidelines at participating study centers will be eligible for the study. Information regarding patient characteristics, findings at screening examination, and patient outcomes will be collected.
Primary Outcome (Primary Aim):
To identify the proportion of patients who meet International Cancer of the Pancreas Screening Consortium screening criteria 3rd update (CAPS Jan 2020), or more updated national guidelines, who are found at the screening to have high-risk pancreatic lesions amenable to treatment (definition of "high-risk lesions amenable to treatment" is provided under the section on study outcomes).
Secondary outcomes (Secondary Aims) will include (details are provided under the section on study outcomes):
- Proportion of patients diagnosed with any stage pancreatic cancer
- proportion of patients undergoing pancreatic surgery
- Cancer-related outcome, defined as a cancer-related death
- proportion of patients experience harms, defined as any complications/adverse event due to screen related procedures
- Comparison of cancer outcome, defined cancer-related death, in screen-detected cancer with cancer outcomes reported by the SEERs population-based registry. Study overview Study type: a prospective observational cohort High-risk patients who meet study inclusion criteria at study centers will be identified.
Screening and patient follow-up will be performed at individual study centers per standard clinical practice. Patient characteristics, screening performed and screening results, clinical outcome data will be collected by individual study centers. This data will be stored and analyzed at central study REDCap located at Beth Israel Deaconess Medical Center (BIDMC)
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Pancreatic Cancer Screening for At-risk Individuals (The Pancreas Scan Study)|
|Actual Study Start Date :||July 10, 2020|
|Estimated Primary Completion Date :||July 10, 2025|
|Estimated Study Completion Date :||July 10, 2026|
Patients who are at high-risk for pancreatic cancer
Patients that meet the eligibility criteria based on CAPS3 or updated national pancreatic cancer screening guidelines
Other: Screening for pancreatic cancer
Screening for pancreatic cancer using EUS or MRI
- Proportion of screening patients found to have high-risk pancreatic lesions amenable to treatment [ Time Frame: From year 1 to year 8, according to the standard of care designated by GI team. ]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: Lesions with high-grade dysplasia (HGD), High-grade pancreatic intraepithelial neoplasia (PanIN), 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, Main duct intra-ductal papillary mucinous neoplasm (IPMN)., Branch-duct IPMN with "worrisome features", cyst associated with an abrupt change in main pancreatic duct caliber with pancreatic atrophy, Neuroendocrine tumor ≥ 2 cm.
- Proportion of screening patients found to have high-risk pancreatic lesions [ Time Frame: From year 1 screening to year 8 screening (annually) ]Proportion of patients who meet CAPS screening eligibility criteria, who are found at screening to have high-risk pancreatic lesions amenable to treatment
- Proportion of screening patients found to have low or moderate-risk pancreatic lesions by screening [ Time Frame: From year 1 to year 8, according to the standard of care designated by GI team. ]
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:
- Branch-duct IPMN without HGD
- Neuroendocrine tumor < 2 cm
- dilation of main pancreatic duct < 8 mm
- Chronic pancreatitis-like change
- Proportion of patients undergoing screening who undergo pancreatic surgery [ Time Frame: From year 1 to year 8.(throughout the duration of the study) ]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
- Proportion of "low yield" pancreatic surgeries performed in screening patients [ Time Frame: From year 1 to year 8.(throughout the duration of the study) ]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.
- Proportion of screening patients who undergo non-pancreatic surgery [ Time Frame: From year 1 to year 8, according to the standard of care designated by GI team ]Proportion of patients who undergo non- pancreatic surgery as a result of screening test results.
- Proportion of screening patients who experience complications/adverse events of screen-related procedures [ Time Frame: From year 1 to year 8, according to standard of care designated by GI team ]Proportion of patients who experienced any complications or adverse events due to screen-related procedures as Endoscopic Ultrasound (EUS), Magnetic resonance cholangiopancreatography (MRCP) or others that have been designated by attending in the GI department. Complications and adverse events will be aggregated to be reported as one value (complications/adverse events). Complications, defined as adverse events that emphasize direct causality between medical care and the adverse outcome or event. Adverse event, defined as an event that may or may not be preventable or result from a medical error
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05006131
|Contact: Andy Silva-Santisteban, MDfirstname.lastname@example.org|
|Contact: Roya Dastjerdi, MPHemail@example.com|
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Roya Dastjerdi, MPH 617-667-4046 firstname.lastname@example.org|
|Principal Investigator: Mandeep Sawhney, MD,MS,FASGE|
|Sub-Investigator: Andy Silva-Santisteban, MD|
|Principal Investigator:||Mandeep Sawhney, MD,MS,FASGE||BIDMC-Harvard Medical School|