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Pancreatic Cancer Early Detection Program (PCEDP)

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ClinicalTrials.gov Identifier: NCT02206360
Recruitment Status : Recruiting
First Posted : August 1, 2014
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Raff, MD, White Plains Hospital

Tracking Information
First Submitted Date July 29, 2014
First Posted Date August 1, 2014
Last Update Posted Date April 30, 2019
Study Start Date April 2014
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 12, 2017)
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 Measures
 (submitted: July 30, 2014)
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.
Change History Complete list of historical versions of study NCT02206360 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 12, 2017)
  • 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 Measures
 (submitted: July 30, 2014)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pancreatic Cancer Early Detection Program
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 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
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.
Condition
  • 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
Intervention
  • Procedure: Endoscopic Ultrasound
  • Procedure: Magnetic Resonance Imaging (MRI)
Study Groups/Cohorts 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 27, 2019)
100
Original Estimated Enrollment
 (submitted: July 30, 2014)
50
Estimated Study Completion Date March 2024
Estimated Primary Completion Date March 2024   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Marisa Cortese, CCRC 914-681-2365 mcortese@wphospital.org
Contact: Nicole Boxer, CGC 914-681-2873 nboxer@wphospital.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02206360
Other Study ID Numbers WPH 1401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Joshua Raff, MD, White Plains Hospital
Study Sponsor White Plains Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account White Plains Hospital
Verification Date April 2019