Clinical Trial 22156

Cancer Type: Gastrointestinal Tumor
Study Type: Screening
NCT#: NCT05692596

Phase: N/A
Principal Investigator: Mok, Shaffer

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Overview

Study Title

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

Summary

This is a project to develop a centralized, real-time, queryable and secure database that integrates data on MCC patients diagnosed with PDAC, pancreatic cystic lesions (benign, pre-cancerous, and malignant), or an inherited PDAC susceptibility, other lower-risk groups, and controls.

Objective

The long-term goal of our PIC is to 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

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria:

18 years of age or older (with the minimum age determined by the age of the majority of individuals to consent), in one of three groups:

Moffitt Cancer Center 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 IPMNs and 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.

Moffitt Cancer Center patients undergoing evaluation for localized/early-stage PDAC.

Moffitt Cancer Center 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 in 3.1.1, 3.1.2, and 3.1.3.

The eligible patient cohorts 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 (MCC 14453), and/or enrollment into the TCC Protocol as a Non-Patient Participant.

Exclusion Criteria

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