Florida Pancreas Collaborative Next Generation Biobank
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03851133|
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : May 18, 2021
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer Cancer Cachexia||Other: Blood Sample Collection Other: Tumor Sample collection Other: Data Collection|
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|
|Estimated Enrollment :||750 participants|
|Official Title:||The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer|
|Actual Study Start Date :||February 26, 2019|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
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.
- Evidence of Precachexia [ Time Frame: 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 Cachexia [ Time Frame: 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.
- Evidence of Refractory Cachexia [ Time Frame: 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.
- Presence of Myopenia [ Time Frame: 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 [ Time Frame: 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.
- Overall Survival [ Time Frame: Up to 24 months ]Overall Survival will be defined as time from surgery to death from any cause
- Progression Free Survival [ Time Frame: Up to 24 months ]Progression Free Survival will be defined as time from surgery to pancreatic cancer recurrence or death.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851133
|United States, Florida|
|Lee Memorial Hospital Regional Cancer Center||Recruiting|
|Fort Myers, Florida, United States, 33905|
|Contact: Mark Bloomston, MD,FACS, FSSO 239-333-0995 firstname.lastname@example.org|
|Principal Investigator: Mark Bloomston, MD,FACS,FSSO|
|University of Florida - Gainesville||Recruiting|
|Gainesville, Florida, United States, 32610-0109|
|Contact: Steven Hughes, MD 352-265-0169 Steven.Hughes@surgery.ufl.edu|
|Principal Investigator: Ziad T Awad, MD, FACS|
|Palmetto General Hospital||Recruiting|
|Hialeah, Florida, United States, 33016|
|Contact: Adrian Legaspi, MD 305-820-6657 Adrian.Legaspi@tenethealth.com|
|Principal Investigator: Adrian Legaspi, MD|
|University of Florida - Jacksonville||Recruiting|
|Jacksonville, Florida, United States, 32209|
|Contact: Ziad T Awad, MD, FACS 904-244-3940 email@example.com|
|Principal Investigator: Ziad T Awad, MD, FACS|
|Lakeland Regional Health||Recruiting|
|Lakeland, Florida, United States, 33805|
|Contact: Manuel A Molina-Vega, MD, FACS 863-603-6565 Manuel.Molina@myLRH.org|
|Principal Investigator: Manuel A Molina-Vega, MD, FACS|
|Mount Sinai Medical Center||Recruiting|
|Miami Beach, Florida, United States, 33140|
|Contact: Philip Bao, MD, FACS 305-674-2397 firstname.lastname@example.org|
|Principal Investigator: Philip Bao, MD, FACS|
|Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Nipun Merchant, MD 305-243-4902 email@example.com|
|Principal Investigator: Nipun Merchant, MD|
|Advent Health - Orlando||Recruiting|
|Orlando, Florida, United States, 32804|
|Contact: Juan Pablo Arnoletti, MD 407-303-7399 firstname.lastname@example.org|
|Principal Investigator: Juan Pablo Arnoletti, MD|
|University of Florida - Orlando||Recruiting|
|Orlando, Florida, United States, 32806|
|Contact: Emilio Alonso, MD 321-841-1858 Emilio.Alonso@orlandohealth.com|
|Principal Investigator: Emilio Alonso, MD|
|St Anthony's Baycare/Bay Surgical Specialists||Recruiting|
|Saint Petersburg, Florida, United States, 33705|
|Contact: Kevin L Huguet, MD, FACS 727-821-8101 email@example.com|
|Principal Investigator: Kevin L Huguet, MD, FACS|
|Principal Investigator: Jami St Julien, MD, MPH|
|Sarasota Memorial Hospital||Recruiting|
|Sarasota, Florida, United States, 34239|
|Contact: Kenneth Meredith, MD, FACS 941-917-9000 firstname.lastname@example.org|
|Principal Investigator: Kenneth Meredith, MD, FACS|
|Tallahassee Memorial Healthcare||Recruiting|
|Tallahassee, Florida, United States, 32308|
|Contact: Wade G Douglas, MD, FACS 850-431-5567 email@example.com|
|Principal Investigator: Wade G Douglas, MD, FACS|
|University of South Florida/Tampa General Hospital||Recruiting|
|Tampa, Florida, United States, 33606|
|Contact: Vic Velanovich, MD 813-844-7393 firstname.lastname@example.org|
|Principal Investigator: Vic Velanovich, MD|
|H Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Karla Ali, MPH 813-745-1060 Karla.Ali@Moffitt.org|
|Contact: Sara Bahl 813-745-4752 Sara.Bahl@moffitt.org|
|Principal Investigator: Jennifer Permuth, PhD, MS|
|Sub-Investigator: Jung Choi, MD, PhD|
|Sub-Investigator: Kathleen Egan, ScD|
|Sub-Investigator: Jason Fleming, MD, FACS|
|Sub-Investigator: Brian Gonzalez, PhD|
|Sub-Investigator: Clement Gwede, PhD, MPH|
|Sub-Investigator: Pamela Hodul, MD|
|Sub-Investigator: Daniel Jeong, MD, MSc|
|Sub-Investigator: Kun Jiang, MD, PhD|
|Sub-Investigator: Jiannong Li, PhD|
|Sub-Investigator: Anthony Magliocco, MD, FRCPC|
|Sub-Investigator: Mokenge Malafa, MD|
|Principal Investigator:||Jennifer Permuth, PhD||H. Lee Moffitt Cancer Center and Research Institute|