Pancreatic Cancer Early Detection Program (PCEDP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02206360|
Recruitment Status : Recruiting
First Posted : August 1, 2014
Last Update Posted : May 15, 2017
|Condition or disease||Intervention/treatment|
|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)|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|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|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2020|
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)|
- 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.
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): 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|