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

January 24, 2024 updated by: H. Lee Moffitt Cancer Center and Research Institute
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33617
        • Recruiting
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Jason Fleming, MD, FACS
        • Sub-Investigator:
          • Jason Denbo, MD
        • Contact:
        • Sub-Investigator:
          • Mokenge Malafa, MD
        • Sub-Investigator:
          • Jennifer Permuth, PhD, MS
        • Principal Investigator:
          • Shaffer Mok, MD, MBS
        • Sub-Investigator:
          • James R Costello, MD, PhD
        • Sub-Investigator:
          • Raj Mohan Paspulati, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients presenting at the Moffitt GI clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Database creation
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Shaffer Mok, MD, MBS, Moffitt Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 11, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-22156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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