Florida Pancreas Collaborative Next Generation Biobank

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03851133

Collaborator

(none)

500

Enrollment

Locations

Anticipated Duration (Months)

35.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

500 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 :

Mar 4, 2019

Actual Primary Completion Date :

Aug 6, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Evidence of Precachexia [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.
Evidence of Cachexia [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.
Evidence of Refractory Cachexia [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.
Presence of Myopenia [Up to 12 months]
Measures of skeletal muscle index (SMI) and psoas muscle index (PMI) for will be used for myopenia assessment.
Presence of Visceral Adiposity [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

Overall Survival [Up to 24 months]
Overall Survival will be defined as time from surgery to death from any cause
Progression Free Survival [Up to 24 months]
Progression Free Survival will be defined as time from surgery to pancreatic cancer recurrence or death.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lee Memorial Hospital Regional Cancer Center	Fort Myers	Florida	United States	33905
2	University of Florida - Gainesville	Gainesville	Florida	United States	32610-0109
3	Palmetto General Hospital	Hialeah	Florida	United States	33016
4	University of Florida - Jacksonville	Jacksonville	Florida	United States	32209
5	Lakeland Regional Health	Lakeland	Florida	United States	33805
6	Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
7	Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital	Miami	Florida	United States	33136
8	Advent Health - Orlando	Orlando	Florida	United States	32804
9	University of Florida - Orlando	Orlando	Florida	United States	32806
10	St Anthony's Baycare/Bay Surgical Specialists	Saint Petersburg	Florida	United States	33705
11	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
12	Tallahassee Memorial Healthcare	Tallahassee	Florida	United States	32308
13	University of South Florida/Tampa General Hospital	Tampa	Florida	United States	33606
14	H Lee Moffitt Cancer Center and Research Institute	Tampa	Florida	United States	33612