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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 : December 24, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease Intervention/treatment
Pancreatic Cancer Cancer Cachexia 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.

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Study Type : Observational
Estimated Enrollment : 750 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 24 months ]
    Overall Survival will be defined as time from surgery to death from any cause

  2. 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
Whole Blood, Plasma, Serum, Tumor tissue from biopsy or surgery, Muscle and fat tissue from surgery


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting at any of the participating sites with a diagnosis or suspicion or pancreatic cancer
Criteria

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

Information from the National Library of Medicine

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


Locations
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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    mark.bloomston@21co.com   
Principal Investigator: Mark Bloomston, MD,FACS,FSSO         
University of Florida - Gainesville Recruiting
Gainesville, Florida, United States, 32610-0109
Contact: Jose G Trevino, MD, FACS    352-265-0761    Jose.Trevino@surgery.ufl.edu   
Principal Investigator: Jose G Trevino, MD, FACS         
University of Florida - Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Ziad T Awad, MD, FACS    904-244-3940    ziad.awad@jax.ufl.edu   
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    philip.bao@msmc.com   
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    nmerchang@med.miami.edu   
Principal Investigator: Nipun Merchant, MD         
Advent Health - Orlando Recruiting
Orlando, Florida, United States, 32804
Contact: Juan Pablo Arnoletti, MD    407-303-7399    pablo.arnoletti.md@flhosp.org   
Principal Investigator: Juan Pablo Arnoletti, MD         
University of Florida - Orlando Recruiting
Orlando, Florida, United States, 32806
Contact: Debashish Bose, MD    407-648-3000    Debashish.Bose@orlandohealth.com   
Principal Investigator: Debashish Bose, MD         
St Anthony's Baycare/Bay Surgical Specialists Recruiting
Saint Petersburg, Florida, United States, 33705
Contact: Kevin L Huguet, MD, FACS    727-821-8101    dr.huguet@baysurgicalspecialists.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    kenneth-meredith@smh.com   
Principal Investigator: Kenneth Meredith, MD, FACS         
Tallahassee Memorial Healthcare Recruiting
Tallahassee, Florida, United States, 32308
Contact: Wade G Douglas, MD, FACS    850-431-5567    wade.douglas@tmh.org   
Principal Investigator: Wade G Douglas, MD, FACS         
University of South Florida/Tampa General Hospital Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Vic Velanovich, MD    813-844-7393    vvelanov@health.usf.edu   
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: Kaleena Dezsi, PhD    813-745-6612    Kaleena.Dezsi@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         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Jennifer Permuth, PhD H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03851133    
Other Study ID Numbers: MCC-19717
8JK02 ( Other Identifier: Florida Department of Health )
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: December 24, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
pancreas
biobank
quantitative imaging
biomarkers
health disparities
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Cachexia
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Pancrelipase
Pancreatin
Gastrointestinal Agents