Florida Pancreas Collaborative Next Generation Biobank

Pancreatic Cancer Clinical Trial

Official title:

The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03851133
• Other study ID #: MCC-19717
• Secondary ID: 8JK02
• Status: Active, not recruiting
• Start date: March 4, 2019
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 1, 2024
• Est. primary completion date: August 6, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
United States	Lee Memorial Hospital Regional Cancer Center	Fort Myers	Florida
United States	University of Florida - Gainesville	Gainesville	Florida
United States	Palmetto General Hospital	Hialeah	Florida
United States	University of Florida - Jacksonville	Jacksonville	Florida
United States	Lakeland Regional Health	Lakeland	Florida
United States	Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital	Miami	Florida
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Advent Health - Orlando	Orlando	Florida
United States	University of Florida - Orlando	Orlando	Florida
United States	St Anthony's Baycare/Bay Surgical Specialists	Saint Petersburg	Florida
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Tallahassee Memorial Healthcare	Tallahassee	Florida
United States	H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	University of South Florida/Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Overall Survival	Overall Survival will be defined as time from surgery to death from any cause	Up to 24 months
Secondary	Progression Free Survival	Progression Free Survival will be defined as time from surgery to pancreatic cancer recurrence or death.	Up to 24 months

External Links

•   Moffitt Cancer Center Clinical Trials Website