Clinical trial NCT01662609: Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer
Official title: Protocol for High-Risk Assessment, Screening, and Early Detection of Pancreatic Cancer at Moffitt Cancer Center and Lehigh Valley Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: pancreas
high-risk
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals potentially at high-risk for developing pancreatic cancer.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Abnormalities Detected by EUS
timeFrame: Average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Aamir Dam, M.D.
role: PRINCIPAL_INVESTIGATOR
References: