The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics

Status: closed to accrual

This study establishes a database for clinical data on Moffitt Cancer Center patients enrolling into the Pancreas Interception Center (PIC). The PIC is designed to educate, identify, and alter the course of individuals who are at risk of pancreatic ductal adenocarcinoma (PDAC) and receive care at Moffitt. By leveraging expertise from a team of experts which include gastroenterologists, pancreatic surgeons, geneticists, radiologists, nutritionists, and epidemiologists, high risk patients can enter a robust lifestyle regimen to alter the course of their pancreas health. The establishment of this database may help develop effective strategies that can be applied clinically at the point-of-care to prevent, intercept, or detect PDAC at an early stage, thereby reducing PDAC burden and saving lives.

Inclusion Criteria

Eligible patients will be 18 years of age or older (with the minimum age determined by the age of the majority of individuals to consent)
MCC patients (Total Cancer Center [TCC] protocol consented or not) a pancreatic cyst, and/or inherited syndrome that predisposes to PDAC. Most relevant pancreatic cysts include intraductal papillary-mucinous neoplasm (IPMNs) and mucinous cystic neoplasm (MCNs). Relevant inherited cancer syndromes include, but are not limited to, hereditary breast and ovarian cancer syndrome, Lynch syndrome, familial adenomatous polyposis, Peutz-Jeghers, hereditary pancreatitis, and familial atypical multiple mole melanoma syndrome
MCC patients undergoing evaluation for localized/early-stage PDAC
MCC patients with a combination of PDAC risk factors such as a history of chronic or new-onset diabetes, pancreatitis, obesity, tobacco exposure, toxin exposure, and/or heavy alcohol consumption
‘Healthy’ control patients who are not in the Moffitt Cancer Registry database and not diagnosed with conditions outlined above
The eligible patient cohorts (above) will be identified through a variety of sources including, but not limited to, ICD codes, billing databases (e.g., FirstCoast - 2008 to May 2011 and Soarian - May 2011 to present), OnCore, and the Moffitt Cancer Registry. Controls (cohort 3.1.3) will be identified via a combination of billing codes for screening colonoscopy, the Lifetime Cancer Screening Protocol (MCC14453), and/or enrollment into the TCC Protocol as a Non-Patient Participant

Exclusion Criteria

Patients not meeting inclusion criteria will be excluded

PRIMARY OBJECTIVES:

I. Establish a centralized, real-time, queryable and secure database that integrates data on Moffitt Cancer Center (MCC) patients diagnosed with PDAC, pancreatic cystic lesions (benign, pre-cancerous, and malignant), or an inherited PDAC susceptibility, other lower-risk groups, and controls.

II. Promote investigator-initiated studies focused on the discovery, translation, and delivery of personalized care for patients with or at increased risk for PDAC.

OUTLINE: This is an observational study.

Participants undergo medical record review while on study.

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The Pancreas Interception Center (PIC) for Early Detection, Prevention, and Novel Therapeutics

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