Pancreatic Cancer Early Detection Program (PCEDP)
|Pancreatic Cancer Pancreas Cancer Pancreatic Adenocarcinoma Familial Pancreatic Cancer BRCA 1/2 HNPCC Lynch Syndrome Hereditary Pancreatitis FAMMM Familial Atypical Multiple Mole Melanoma Peutz Jeghers Syndrome||Procedure: Endoscopic Ultrasound Procedure: Magnetic Resonance Imaging (MRI)|
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Other
Time Perspective: Prospective
|Target Follow-Up Duration:||5 Years|
|Official Title:||Observational Study to Analyze the Outcomes of Subjects Who - Based Upon Their Sufficiently Elevated Risk for the Development of Pancreatic Adenocarcinoma- Elect to Undergo Early Detection Testing|
- Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing. [ Time Frame: 5 years ]Number of Participants with Premalignant or Malignant Pancreatic Conditions, as a Measure of Safety and Efficacy
- Clinical outcomes which occur as a result of this Protocol [ Time Frame: 5 years ]Prospective collection and reporting of any malignant conditions which occur as a result of this Protocol, including from surgery, or other testing.
- Complications of any interventions as a result of this Protocol [ Time Frame: 5 years ]Prospective collection and reporting of any complications that may be associated with early detection testing, including hospitalization, disability, and death.
- Non-Pancreatic cancers diagnosed while on this protocol [ Time Frame: 5 years ]Prospective collection and reporting of non-pancreatic cancers detected during this Protocol, including pancreatic cysts.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||March 2020|
|Estimated Primary Completion Date:||March 2019 (Final data collection date for primary outcome measure)|
Individuals at elevated risk for pancreatic cancer
Individuals with an elevated risk of developing pancreatic cancer as either equal to or greater than five times the general population risk, or five times the average risk (1.5%) of developing pancreatic cancer by age 70; that is a 7.5% lifetime risk.
|Procedure: Endoscopic Ultrasound Procedure: Magnetic Resonance Imaging (MRI)|
Interested individuals can be referred by physicians, or by family or friends.
Individuals are informed that the purpose of this study is to collect outcome data following early detection testing based upon our criteria for elevated risk.
Consent is obtained by any of the co-investigators. Consent is obtained for the primary PCEDP, and also obtained to allow for data to be used by our Cancer Program.
We have a weekly review of all calls made and of all enrollments.
We have a monthly meeting to review all proceeding regarding the study.
Our IRB routinely reviews the proceedings of the study
Our institution has a monthly Clinical research Committee meeting.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02206360
|Contact: Diana Zondorak, CCRCfirstname.lastname@example.org|
|Contact: Nicole Boxer, CGCemail@example.com|
|United States, New York|
|White Plains Hospital||Recruiting|
|White Plains, New York, United States, 10601|
|Contact: Una Hopkins, DNP 914-681-2034 firstname.lastname@example.org|
|Principal Investigator: Joshua P Raff, MD|
|Sub-Investigator: Sara Sadan, MD|
|Sub-Investigator: Dan Costin, MD|
|Sub-Investigator: Charles Noyer, MD|
|Sub-Investigator: Mark Gordon, MD|
|Sub-Investigator: Nicole Boxer, CGC|