Florida Pancreas Collaborative Next Generation Biobank

NCT ID: NCT03851133

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-04

Study Completion Date

2026-06-11

Brief Summary

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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

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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.

Conditions

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Pancreatic Cancer Cancer Cachexia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

Blood samples, tumor samples and data will be collected from all participants as applicable.

Blood Sample Collection

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Permuth, PhD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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Lee Memorial Hospital Regional Cancer Center

Fort Myers, Florida, United States

Site Status

University of Florida - Gainesville

Gainesville, Florida, United States

Site Status

Palmetto General Hospital

Hialeah, Florida, United States

Site Status

University of Florida - Jacksonville

Jacksonville, Florida, United States

Site Status

Lakeland Regional Health

Lakeland, Florida, United States

Site Status

Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status

Advent Health - Orlando

Orlando, Florida, United States

Site Status

University of Florida - Orlando

Orlando, Florida, United States

Site Status

Sarasota Memorial Hospital

Sarasota, Florida, United States

Site Status

St Anthony's Baycare/Bay Surgical Specialists

St. Petersburg, Florida, United States

Site Status

Tallahassee Memorial Healthcare

Tallahassee, Florida, United States

Site Status

University of South Florida/Tampa General Hospital

Tampa, Florida, United States

Site Status

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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8JK02

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-19717

Identifier Type: -

Identifier Source: org_study_id

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