Florida Pancreas Collaborative Next Generation Biobank

The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer

The goal of this study is to partner with individuals known or suspected to have pancreatic cancer to build a biobank dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a resource that involves collection, processing and storage of blood, other bodily fluids, and tissue.

Study Overview

• Status: Active, not recruiting
• Conditions: Pancreatic Cancer; Cancer Cachexia
• Intervention / Treatment: Other: Blood Sample Collection; Other: Tumor Sample collection; Other: Data Collection

Detailed Description

Doctors, researchers, and patient advocates from numerous institutions throughout the state of Florida have formed a partnership known as the Florida Pancreas Collaborative. The goals of the Florida Pancreas Collaborative team are to find better ways to diagnose and treat pancreatic cancer and improve quality of life. Recent research suggests that pancreatic cancer affects people of various racial and ethnic groups differently, with some groups having more aggressive disease and a poorer prognosis than other groups.

In this research study, the investigators want to partner with individuals known or suspected to have pancreatic cancer to build a 'biobank' dedicated to minimizing disparities and personalizing care for individuals affected by pancreatic cancer. A biobank is a valuable resource that involves collection, processing, and storage of blood, other bodily fluids, and tissue (obtained during biopsy or surgery) to improve the investigator's understanding of health and disease. When combined with information and medical images obtained through routine care, the investigators will be able to investigate biological processes that may underlie differences and poor outcomes and target them with more effective therapeutic strategies tailored to the individual.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33905
      • Lee Memorial Hospital Regional Cancer Center
    • Gainesville, Florida, United States, 32610-0109
      • University of Florida - Gainesville
    • Hialeah, Florida, United States, 33016
      • Palmetto General Hospital
    • Jacksonville, Florida, United States, 32209
      • University of Florida - Jacksonville
    • Lakeland, Florida, United States, 33805
      • Lakeland Regional Health
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Orlando, Florida, United States, 32804
      • Advent Health - Orlando
    • Orlando, Florida, United States, 32806
      • University of Florida - Orlando
    • Saint Petersburg, Florida, United States, 33705
      • St Anthony's Baycare/Bay Surgical Specialists
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial HealthCare
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center and Research Institute
    • Tampa, Florida, United States, 33606
      • University of South Florida/Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at any of the participating sites with a diagnosis or suspicion or pancreatic cancer

Description

Inclusion Criteria:

• 18 years of age or older.
• Patient presents for evaluation at a participating site with a strong clinical suspicion or diagnosis of a pancreatic cancer primary based on symptoms, imaging, biopsy, and/or blood-work and has not had treatment.
• Patient self-reports as Non-Hispanic White, African American, or Hispanic.
• Able to understand and voluntarily sign the informed consent.
• Willing to complete study questionnaire(s) and donate medical images and biological specimens (including tissue and blood) obtained at the time of standard of care procedures (biopsy, surgery, and/or venipuncture) after signing the informed consent document.

Exclusion Criteria:

• No suspicion or diagnosis of pancreatic cancer.
• Has a diagnosis of pancreatic cancer but and has already undergone treatment (which may include surgery, chemotherapy, and/or radiation).
• Self-reported race/ethnicity other than Non-Hispanic White, African American, or Hispanic.
• Unable to provide informed consent.
• Unwilling to complete study questionnaires(s) and/or donate biological specimens

Study Plan

How is the study designed?

Design Details

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All Participants; Blood samples, tumor samples and data will be collected from all participants as applicable.

Other: Blood Sample Collection; Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date) and at the time of follow-up (approximately 6 months and approximately 12 months after baseline).; Other: Tumor Sample collection; At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue and tissue from site of metastasis will be collected.; Other: Data Collection; Participants will be asked to complete a 3 page screening tool at the time of their in-person clinic visit, as well as questionnaires at baseline and at 6 and 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evidence of Precachexia	Cases will be evaluated for precachexia using the following guidelines: Anorexia with <5% weight loss over past 6 months along with metabolic changes that together indicate precachexia.	Up to 12 months
Evidence of Cachexia	Cases will be evaluated for cachexia using the following guidelines: Anorexia with >5% weight loss over past 6 months, along with metabolic changes that together indicate cachexia.	Up to 12 months
Evidence of Refractory Cachexia	Cases will be evaluated for refractory cachexia using the following guidelines: Anorexia >5% weight loss over 6 months along with specific metabolic changes that together indicate refractory cachexia.	Up to 12 months
Presence of Myopenia	Measures of skeletal muscle index (SMI) and psoas muscle index (PMI) for will be used for myopenia assessment.	Up to 12 months
Presence of Visceral Adiposity	Using CT scans at the axial L2-L3 level, the following radiologic measures of abdominal adiposity will be obtained: visceral fat area (VFA), subcutaneous fat area (SFA), total abdominal fat (TAF) area, and the VFA to SFA ratio (V/S). The VFA to SFA ratio (V/S) will be calculated with V/S > 0.4 defined as viscerally obese.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Overall Survival will be defined as time from surgery to death from any cause	Up to 24 months
Progression Free Survival	Progression Free Survival will be defined as time from surgery to pancreatic cancer recurrence or death.	Up to 24 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Jennifer Permuth, PhD, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): August 6, 2022
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: February 12, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: biomarkers; pancreas; biobank; health disparities; quantitative imaging
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Body Weight; Body Weight Changes; Pancreatic Diseases; Weight Loss; Thinness; Pancreatic Neoplasms; Cachexia
• Other Study ID Numbers: MCC-19717; 8JK02 (Other Identifier: Florida Department of Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Investigators requesting to use Florida Pancreas Collaborative (FPC) data, images, and/or biospecimens will need to submit a written proposal to the FPC biobank utilization committee. Decisions will be based on scientific merit, specimen availability, experience of the requesting investigator, and resources to conduct proposed methods. De-identified samples and/or data will be released if the concept receives approval and after scientific review committee and IRB approval is obtained, conflict of interests are checked, and a material transfer agreement is established. Intellectual property issues will need to be agreed upon. If access is granted, the biobank utilization committee may monitor the Investigator's Research studies to ensure appropriate use of the biospecimens and/or data. The Investigator shall provide a written summary of their research findings and reference this funding source in future manuscripts and presentations.
• IPD Sharing Time Frame: Will be available approximately one year after study ends, approximately September 2022. End of availability undetermined at this time.
• IPD Sharing Access Criteria: Data and specimens will be shared with researchers interested in this topic area who wish to pursue analyses that may be descriptive, analytic, molecular, or correlative in nature. The access criteria used to share IPD and any additional supporting information will involve a formal process which involves submitting a written proposal to the FPC biobank utilization committee. Decisions will be based on scientific merit, specimen availability, experience of the requesting investigator, and resources to conduct proposed methods. Samples and/or data will be released if the concept receives approval and after scientific review committee and IRB approval is obtained, conflict of interests (COI) are checked, a material transfer agreement is established between institutions, and intellectual property issues are agreed upon. The release of data will be based on the nature of the request and can represent aggregate or individual-level data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No