2019-03-04
2022-08-06
2025-07-05
500
NCT03851133
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
OBSERVATIONAL
Florida Pancreas Collaborative Next Generation Biobank
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-02-12 | N/A | 2025-02-19 |
2019-02-20 | N/A | 2025-02-20 |
2019-02-22 | N/A | 2025-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : All Participants Blood samples, tumor samples and data will be collected from all participants as applicable. | OTHER: Blood Sample Collection
OTHER: Tumor Sample collection
OTHER: Data Collection
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
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