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Pancreatic Cancer Early Detection Program (PCEDP)

This study is currently recruiting participants.
Verified May 2017 by Joshua Raff, MD, White Plains Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02206360
First Posted: August 1, 2014
Last Update Posted: May 15, 2017
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.
Information provided by (Responsible Party):
Joshua Raff, MD, White Plains Hospital
July 29, 2014
August 1, 2014
May 15, 2017
April 2014
March 2019   (Final data collection date for primary outcome measure)
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
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.
Complete list of historical versions of study NCT02206360 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Pancreatic Cancer Early Detection Program
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
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.

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.

Observational [Patient Registry]
Observational Model: Other
Time Perspective: Prospective
5 Years
Not Provided
Non-Probability Sample
Individuals aged 18 and older, who carry sufficiently elevated risk for the development of pancreatic cancer, numerically defined as over (or near) 5 times the general population risk, as determined by their personal, familial, or genetic history.
  • 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)
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.
Interventions:
  • Procedure: Endoscopic Ultrasound
  • Procedure: Magnetic Resonance Imaging (MRI)
Not Provided
 
Recruiting
50
March 2020
March 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria: Any of the following:

  1. Known carrier of either the BRCA2 or CDKN2A mutation;
  2. Known carrier of any of the following mutations (BRCA1, MLH1, MSH2, PMS2, MSH6, EPCAM , P53, PALB2, APC, or ATM) PLUS first or second degree relative affected with pancreatic cancer;
  3. Individual with Peutz-Jeghers Syndrome;
  4. Familial Pancreatic Cancer, defined as at least two affected relatives with Pancreatic Cancer, who are first degree relatives with each other, and at least one of those affected must be first degree relative to the study subject;
  5. Both parents affected, any age:
  6. Any first degree relative diagnosed with pancreatic cancer under age 50;
  7. Chronic Pancreatitis Syndrome, defined by either PRSS1 or SPINK1 mutations AND appropriate clinical and family history

Exclusion Criteria:

  1. Any medical condition that contraindicates endoscopy or biopsy
  2. Any medical condition that contraindicates MRI
  3. Status post partial or complete resection of the pancreas
  4. History of pancreatic cancer, either endocrine or exocrine
  5. Clinical suspicion of pancreatic cancer, or any previous radiographic or histologic diagnosis of a pre-malignant finding, including IPMN (Intraductal papillary mucinous neoplasm) and PanIN (Pancreatic intraepithelial Neoplasm).
  6. diagnosis of dementia
  7. Uncontrolled, current illness
  8. Renal insufficiency with serum creatinine greater than 2.0 mg/dl
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Diana Zondorak, CCRC 914-681-2365 dzondorak@wphospital.org
Contact: Nicole Boxer, CGC 914-681-2873 nboxer@wphospital.org
United States
 
 
NCT02206360
WPH 1401
Yes
Not Provided
Not Provided
Joshua Raff, MD, White Plains Hospital
White Plains Hospital
Not Provided
Not Provided
White Plains Hospital
May 2017