Florida Pancreas Collaborative Next Generation Biobank
The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer
2 other identifiers
observational
500
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2019
CompletedFirst Posted
Study publicly available on registry
February 22, 2019
CompletedStudy Start
First participant enrolled
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2026
ExpectedDecember 5, 2025
December 1, 2025
3.4 years
February 12, 2019
December 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (2)
Overall Survival
Up to 24 months
Progression Free Survival
Up to 24 months
Study Arms (1)
All Participants
Blood samples, tumor samples and data will be collected from all participants as applicable.
Interventions
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.
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).
At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue and tissue from site of metastasis will be collected.
Eligibility Criteria
Patients presenting at any of the participating sites with a diagnosis or suspicion or pancreatic cancer
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Lee Memorial Hospital Regional Cancer Center
Fort Myers, Florida, 33905, United States
University of Florida - Gainesville
Gainesville, Florida, 32610-0109, United States
Palmetto General Hospital
Hialeah, Florida, 33016, United States
University of Florida - Jacksonville
Jacksonville, Florida, 32209, United States
Lakeland Regional Health
Lakeland, Florida, 33805, United States
Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
Miami, Florida, 33136, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Advent Health - Orlando
Orlando, Florida, 32804, United States
University of Florida - Orlando
Orlando, Florida, 32806, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
St Anthony's Baycare/Bay Surgical Specialists
St. Petersburg, Florida, 33705, United States
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308, United States
University of South Florida/Tampa General Hospital
Tampa, Florida, 33606, United States
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Related Links
Biospecimen
Whole Blood, Plasma, Serum, Tumor tissue from biopsy or surgery, Muscle and fat tissue from surgery
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Permuth, PhD
H. Lee Moffitt Cancer Center and Research Institute
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2019
First Posted
February 22, 2019
Study Start
March 4, 2019
Primary Completion
August 6, 2022
Study Completion (Estimated)
June 11, 2026
Last Updated
December 5, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Will be available approximately one year after study ends, approximately September 2022. End of availability undetermined at this time.
- 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.
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.