2020-07-10
2032-12-31
2032-12-31
1395
NCT05006131
Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
OBSERVATIONAL
Pancreatic Cancer Screening for At-risk Individuals
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.
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): 1. Proportion of patients diagnosed with any stage pancreatic cancer 2. proportion of patients undergoing pancreatic surgery 3. Cancer-related outcome, defined as a cancer-related death 4. proportion of patients experience harms, defined as any complications/adverse event due to screen related procedures 5. 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)
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 |
|---|---|---|
2021-07-18 | N/A | 2024-11-05 |
2021-08-07 | N/A | 2024-11-07 |
2021-08-16 | N/A | 2024-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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: 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. | 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | From year 1 screening to year 12 (end of at least 5 years follow up in 2032) screening (annually) |
| 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 | 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. |
| 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 | 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) |
| 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. | 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) |
| Proportion of screening patients who undergo non-pancreatic surgery | Proportion of patients who undergo non- pancreatic surgery as a result of screening test results. | From year 1 to year 12 (the end of at least 5 years follow up in 2032), according to the standard of care designated by GI team |
| Proportion of screening patients who experience complications/adverse events of screen-related procedures | 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 | From year 1 to year 12 (the end of at least 5 years follow up in 2032), according to standard of care designated by GI team |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Roya Dastjerdi, MD Phone Number: 617-667-4046 Email: rdastjer@bidmc.harvard.edu |
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:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
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