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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
  Purpose
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.

Condition Intervention
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

Resource links provided by NLM:


Further study details as provided by Joshua Raff, MD, White Plains Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Groups/Cohorts Assigned Interventions
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)

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Diana Zondorak, CCRC 914-681-2365 dzondorak@wphospital.org
Contact: Nicole Boxer, CGC 914-681-2873 nboxer@wphospital.org

Locations
United States, New York
White Plains Hospital Recruiting
White Plains, New York, United States, 10601
Contact: Una Hopkins, DNP    914-681-2034    uhopkins@wphospital.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         
Sponsors and Collaborators
White Plains Hospital
  More Information

Responsible Party: Joshua Raff, MD, Chief, Oncology & Hematology Section, White Plains Hospital
ClinicalTrials.gov Identifier: NCT02206360     History of Changes
Other Study ID Numbers: WPH 1401
First Submitted: July 29, 2014
First Posted: August 1, 2014
Last Update Posted: May 15, 2017
Last Verified: May 2017

Keywords provided by Joshua Raff, MD, White Plains Hospital:
Pancreatic Cancer
Pancreatic Cancer Screening
Pancreas Cancer
Pancreatic Adenocarcinoma
Pancreatic Adenocarcinoma screening
Familial Pancreatic Cancer
BRCA 1/2
HNPCC
Lynch Syndrome
Hereditary Pancreatitis
FAMMM
Familial atypical multiple mole melanoma
Peutz Jeghers Syndrome
MRI
Magnetic Resonance Imaging
EUS
Endoscopic Ultrasound
Early detection
Screening

Additional relevant MeSH terms:
Syndrome
Melanoma
Adenocarcinoma
Pancreatic Neoplasms
Pancreatitis
Colorectal Neoplasms, Hereditary Nonpolyposis
Peutz-Jeghers Syndrome
Pancreatitis, Chronic
Carcinoma
Dysplastic Nevus Syndrome
Disease
Pathologic Processes
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms, Glandular and Epithelial
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Neoplastic Syndromes, Hereditary