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Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center

30 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center

Inclusion Criteria:

- Patients will be eligible if they have 2 or more relatives with pancreatic cancer and
have a first degree relationship with at least one of the relatives with pancreatic

- If only 2 family members are affected then both must have had pancreatic cancer
and a first-degree relationship with individual screened

- If there are more than 2 affected individuals on the same side of the family at
least one of the individuals must have a first-degree relationship with the
member being screened

- Patients at least 40 years old or 10 years younger than the youngest affected

- Peutz-Jeghers Syndrome (PJS) patients age>30

- Hereditary pancreatitis patients

- Patients with Familial Atypical Multiple Mole Melanoma Syndrome (FAMMM)

- Patients with BRCA2 mutation and at least one first or second degree relative with
documented pancreatic cancer

- Willingness to undergo (EUS) with possible Fine Needle Aspiration (FNA)

- Willingness to undergo surgical evaluation for abnormal EUS/FNA finding

- Willingness to undergo radiographic evaluation if screening findings are abnormal

Exclusion Criteria:

- Medical contraindications to undergoing endoscopy or obstruction of the GI tract that
precludes passage of the endoscope

- Personal history of pancreatic adenocarcinoma

- Previous partial or complete resection of the pancreas for adenocarcinoma

- Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastamosis

- Previous computed tomography (CT) scan, magnetic resonance imaging/magnetic resonance
cholangiopancreatography (MRI/MRCP) or EUS of the abdomen in the past 3 years

- Coexisting cancer in other organs or acquired immunodeficiency syndrome/human
immunodeficiency virus (AIDS/HIV)

- Life expectancy less than 5 years

- Pregnancy

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Number of Abnormalities Detected by EUS

Outcome Description:

To determine whether targeted screening of these high-risk individuals using Endoscopic Ultrasound (EUS) at regular intervals can detect precancerous pancreas changes or early stage asymptomatic pancreatic cancer.

Outcome Time Frame:

Average of 5 years

Safety Issue:


Principal Investigator

Jason Klapman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

June 2007

Completion Date:

September 2017

Related Keywords:

  • Pancreatic Cancer
  • pancreas
  • high-risk
  • Pancreatic Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612