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



Status:Active, not recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:30 - Any
Updated:12/6/2018
Start Date:June 1, 2007
End Date:June 2020

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

The purpose of this study is to find out whether Endoscopic Ultrasound (EUS) can detect early
stage pre-cancerous or cancerous changes in the pancreas in patients at high-risk for the
development of pancreatic cancer. Endoscopic refers to the use of an instrument called an
endoscope - a thin, flexible tube with a tiny video camera and light on the end. Ultrasound
refers to an imaging technique that uses sound waves to produce pictures. EUS in this
research study is a method of combining endoscopy and ultrasound imaging to obtain high
quality images of the pancreas.


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
cancer

- 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
individual

- 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
We found this trial at
2
sites
Allentown, Pennsylvania 18105
Principal Investigator: Rohit Sharma, M.D.
Phone: 813-745-6993
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Jason Klapman, M.D.
Phone: 813-745-4075
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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