Florida Pancreas Collaborative Next Generation Biobank

N/AActive Not RecruitingNCT03851133

H. Lee Moffitt Cancer Center and Research Institute500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Pancreatic Cancer Cancer Cachexia

Interventions

Blood Sample CollectionOTHER

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).

Tumor Sample collectionOTHER

At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue and tissue from site of metastasis will be collected.

Data CollectionOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Lee Memorial Hospital Regional Cancer Center

Fort Myers, Florida, United States

University of Florida - Gainesville

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 12 months

Secondary Outcomes

Overall Survival

Overall Survival will be defined as time from surgery to death from any cause

Time frame: Up to 24 months

Progression Free Survival

Data from ClinicalTrials.gov

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