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

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05692596

Collaborator

(none)

500

Enrollment

Location

33.8

Anticipated Duration (Months)

14.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Ductal Adenocarcinoma Pancreatic Cyst Chronic Pancreatitis Fatty Pancreas Genetic Pancreatic Cancer Genetic Pancreatitis BRCA Mutation Lynch Syndrome FAP Familial Atypical Multiple Mole-Melanoma PALB2 Gene Mutation Peutz-Jeghers Syndrome Ataxia Telangiectasia	Other: Data collection

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 6, 2022

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
All participants Participants include patients scheduled to see the clinical team in the Pancreas Interception Center (PIC) which will be housed in the Moffitt GI Clinic.	Other: Data collection Investigators will compile data typically collected clinically. This data will include demographics, cancer screening procedures, cancer diagnosis and staging, chemotherapy, immunotherapy, radiation therapy, surgery, comorbidities, medication use, lifestyle and other cancer risk factors, quality of life, vital status, and molecular data generated from specimens collected clinically.

Arm

Intervention/Treatment

All participants

Participants include patients scheduled to see the clinical team in the Pancreas Interception Center (PIC) which will be housed in the Moffitt GI Clinic.

Other: Data collection

Investigators will compile data typically collected clinically. This data will include demographics, cancer screening procedures, cancer diagnosis and staging, chemotherapy, immunotherapy, radiation therapy, surgery, comorbidities, medication use, lifestyle and other cancer risk factors, quality of life, vital status, and molecular data generated from specimens collected clinically.

Outcome Measures

Primary Outcome Measures

Database creation [24 months]
A centralized, real-time, queryable and secure database will be developed that will integrate data on Moffitt patients diagnosed with pancreatic ductal adenocarcinoma (PDAC), pancreatic cystic lesions (benign, pre-cancerous and malignant), or an inherited PDAC susceptibility.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years of age or older
Moffitt Cancer Center patients presenting with a pancreatic cyst, and/or inherited syndrome that predisposes them to pancreatic ductal adenocarcinoma (PDAC)
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.