Clinical Trial: Pancreatic Cancer

Pancreatic Cancer Screening and Detection Study (PRO00001855)

Full Name

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

Description

Patients who agree to participate will be scheduled for a procedure called an endoscopic ultrasound (EUS). The EUS is performed in the Gastroenterology Endoscopy Unit. The EUS screening is not standard of care. While the EUS screening is experimental in this study, EUS is approved for screening for other indications. Participants will be given anesthesia, and once sedated, an ultrasound scope will be passed through the participant’s mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. At the same time patients sign the consent to be in the research study, they will be given a procedural consent to sign so that a biopsy may be performed to obtain a diagnosis in the event the EUS shows an abnormality. It is standard of care to biopsy the abnormal growth. To prepare for the EUS, participants need to stop eating and drinking at midnight the night before the procedure. Participants will need to be off certain medications, such as Coumadin, Plavix, aspirin, and non-steroidal anti-inflammatory drugs (NSAIDs) at least 5 days before the procedure is scheduled. If the initial EUS is normal, participants will have a repeat EUS on a yearly basis unless the results become abnormal. If the results become abnormal, participants will be treated according to standard medical therapy.  

Eligibility

Inclusion Criteria
Inclusion Criteria-including but may not be limited to: Must meet 1 of the following 5 criteria Must have 2 or more relatives with pancreatic cancer and have a first degree relationship with at least 1 of the relatives with pancreatic cancer Have a condition called Peutz-Jeghers Syndrome and are older than 30 years Have hereditary pancreatitis Have familial Atypical Multiple Mole Melanoma Syndrome (FAMMM) (p16 mutation) Being BRCA2 positive and having one first or second degree relative with pancreatic cancer Addition criteria includes: Must be willing to undergo endoscopic ultrasound (EUS) with possible fine needle aspiration Must be willing to undergo radiographic evaluation if the screening findings are abnormal Must not have a personal history of pancreatic adenocarcinoma Must not have had previous CT scan, MRI/MRCP or EUS of the abdomen in the past 3 years Must not have coexisting cancer in other organs or AIDS/HIV