Clinical Trial: Pancreatic Cancer Early Detection Program

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

Brief Summary: Early detection testing is recommended for individuals at elevated risk for the development of Pancreatic Cancer. This Protocol will define sufficiently elevated risk 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. Our inclusion criteria has a strong focus on the risk for pancreatic cancer imparted by the presence of hereditary cancer genes, as well as by family history. Enrolled subjects will undergo Endoscopic Ultrasound (EUS) alternating with Magnetic Resonance Imaging (MRI), every six to 12 months, for up to 5 years.

Detailed Summary:

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.


Sponsor: White Plains Hospital

Current Primary Outcome: 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


Original Primary Outcome: Premalignant or malignant pancreatic conditions found with alternating EUS and MRI testing. [ Time Frame: 5 years ]

Prospective analysis of number, type, and location of premalignant or malignant pancreatic conditions detected, and their associations with genetic, familial, or medical predispositions.


Current Secondary Outcome:

  • 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.


Original Secondary Outcome:

  • Clinical outcomes which occur as a result of this Protocol [ Time Frame: 5 years ]
    Prospective collection and reporting of any interventions which occur as a result of this Protocol, including surgery, or other cancer treatments.
  • 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.


Information By: White Plains Hospital

Dates:
Date Received: July 29, 2014
Date Started: April 2014
Date Completion: March 2020
Last Updated: May 12, 2017
Last Verified: May 2017