Florida Pancreas Collaborative Next Generation Biobank
- Conditions
- Cancer CachexiaPancreatic Cancer
- Interventions
- Other: Blood Sample CollectionOther: Tumor Sample collectionOther: Data Collection
- Registration Number
- NCT03851133
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All Participants Data Collection Blood samples, tumor samples and data will be collected from all participants as applicable. All Participants Tumor Sample collection Blood samples, tumor samples and data will be collected from all participants as applicable. All Participants Blood Sample Collection Blood samples, tumor samples and data will be collected from all participants as applicable.
- Primary Outcome Measures
Name Time Method Evidence of Precachexia Up to 12 months 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.
Evidence of Refractory Cachexia Up to 12 months 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.
Evidence of Cachexia Up to 12 months 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.
Presence of Myopenia Up to 12 months Measures of skeletal muscle index (SMI) and psoas muscle index (PMI) for will be used for myopenia assessment.
Presence of Visceral Adiposity Up to 12 months 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.
- Secondary Outcome Measures
Name Time Method Progression Free Survival Up to 24 months Progression Free Survival will be defined as time from surgery to pancreatic cancer recurrence or death.
Overall Survival Up to 24 months Overall Survival will be defined as time from surgery to death from any cause
Trial Locations
- Locations (14)
Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
H Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
University of Florida - Orlando
🇺🇸Orlando, Florida, United States
St Anthony's Baycare/Bay Surgical Specialists
🇺🇸Saint Petersburg, Florida, United States
Lee Memorial Hospital Regional Cancer Center
🇺🇸Fort Myers, Florida, United States
University of Florida - Jacksonville
🇺🇸Jacksonville, Florida, United States
Tallahassee Memorial Healthcare
🇺🇸Tallahassee, Florida, United States
University of South Florida/Tampa General Hospital
🇺🇸Tampa, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Advent Health - Orlando
🇺🇸Orlando, Florida, United States
Palmetto General Hospital
🇺🇸Hialeah, Florida, United States
Lakeland Regional Health
🇺🇸Lakeland, Florida, United States
Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Florida - Gainesville
🇺🇸Gainesville, Florida, United States