Clinical trial NCT03851133: Florida Pancreas Collaborative Next Generation Biobank
Official title: The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pancreatic Cancer
Cancer Cachexia
Keywords: pancreas
biobank
quantitative imaging
biomarkers
health disparities
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at any of the participating sites with a diagnosis or suspicion or pancreatic cancer

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.

Eligibility 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

Primary outcomes:
measure: Evidence of Precachexia
timeFrame: Up to 12 months
measure: Evidence of Cachexia
timeFrame: Up to 12 months
measure: Evidence of Refractory Cachexia
timeFrame: Up to 12 months
measure: Presence of Myopenia
timeFrame: Up to 12 months
measure: Presence of Visceral Adiposity
timeFrame: Up to 12 months
Secondary outcomes:
measure: Overall Survival
timeFrame: Up to 24 months
measure: Progression Free Survival
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Fort Myers
country: United States
facility: Lee Memorial Hospital Regional Cancer Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Gainesville
state: Florida
city: Hialeah
country: United States
facility: Palmetto General Hospital
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - Jacksonville
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Health
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
state: Florida
city: Orlando
country: United States
facility: Advent Health - Orlando
state: Florida
city: Orlando
country: United States
facility: University of Florida - Orlando
state: Florida
city: Saint Petersburg
country: United States
facility: St Anthony's Baycare/Bay Surgical Specialists
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Healthcare
state: Florida
city: Tampa
country: United States
facility: University of South Florida/Tampa General Hospital
state: Florida
city: Tampa
country: United States
facility: H Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Jennifer Permuth, PhD
role: PRINCIPAL_INVESTIGATOR
References: