Pancreatic CancerNCT03851133
Florida Pancreas Collaborative Next Generation Biobank
An observational study of Pancreatic Cancer and Cancer Cachexia, run by H. Lee Moffitt Cancer Center and Research Institute at 14 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Cancer Cachexia
- What is being tested?
- Blood Sample Collection, Tumor Sample collection and Data Collection
- How many people
- 500 participants
- Where
- 14 sitesUnited States
- Study dates
- 4 Mar 2019to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients presenting at any of the participating sites with a diagnosis or suspicion or pancreatic cancer
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Lee Memorial Hospital Regional Cancer Center
Fort Myers, Florida, 33905
University of Florida - Gainesville
Gainesville, Florida, 32610-0109
Palmetto General Hospital
Hialeah, Florida, 33016
University of Florida - Jacksonville
Jacksonville, Florida, 32209
Lakeland Regional Health
Lakeland, Florida, 33805
Sylvester Comprehensive Cancer Center & Jackson Memorial Hospital
Miami, Florida, 33136
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Advent Health - Orlando
Orlando, Florida, 32804
University of Florida - Orlando
Orlando, Florida, 32806
Sarasota Memorial Hospital
Sarasota, Florida, 34239
St Anthony's Baycare/Bay Surgical Specialists
St. Petersburg, Florida, 33705
Tallahassee Memorial Healthcare
Tallahassee, Florida, 32308
University of South Florida/Tampa General Hospital
Tampa, Florida, 33606
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer
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.
Read the 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.
- Conditions
- Pancreatic Cancer, Cancer Cachexia
- Being tested
- Blood Sample Collection, Tumor Sample collection, Data Collection
- Keywords
- pancreas, biobank, quantitative imaging, biomarkers, health disparities
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Blood samples, tumor samples and data will be collected from all participants as applicable. Receives: Other: Blood Sample Collection; Other: Tumor Sample collection; Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Secondary outcomes (2)
Overall Survival
Overall Survival will be defined as time from surgery to death from any cause
Measured: Up to 24 months
Progression Free Survival
Progression Free Survival will be defined as time from surgery to pancreatic cancer recurrence or death.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start4 Mar 2019
- Primary completion6 Aug 2022
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Permuth, PhD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851133
- Sponsor's protocol ID
- MCC-19717
- Other IDs
- 8JK02
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2019
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators requesting to use Florida Pancreas Collaborative (FPC) data, images, and/or biospecimens will need to submit a written proposal to the FPC biobank utilization committee. Decisions will be based on scientific merit, specimen availability, experience of the requesting investigator, and resources to conduct proposed methods. De-identified samples and/or data will be released if the concept receives approval and after scientific review committee and IRB approval is obtained, conflict of interests are checked, and a material transfer agreement is established. Intellectual property issues will need to be agreed upon. If access is granted, the biobank utilization committee may monitor the Investigator's Research studies to ensure appropriate use of the biospecimens and/or data. The Investigator shall provide a written summary of their research findings and reference this funding source in future manuscripts and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03851133
- Acronym / sponsor ID
- MCC-19717
- Conditions
- Pancreatic Cancer, Cancer Cachexia
- Keywords
- pancreas, biobank, quantitative imaging, biomarkers, health disparities
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 6 Aug 2022 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: Blood Sample Collection, Other: Tumor Sample collection, Other: Data CollectionBlood samples, tumor samples and data will be collected from all participants as applicable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at any of the participating sites with a diagnosis or suspicion or pancreatic cancer
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample CollectionParticipants 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 | All Participants |
| Tumor Sample collectionAt the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue and tissue from site of metastasis will be collected. | Other | All Participants |
| Data CollectionParticipants 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. | Other | All Participants |
Primary outcome
Evidence of Precachexia
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Overall Survival
Time frame: Up to 24 months
Progression Free Survival
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Moffitt Cancer Center Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Investigators requesting to use Florida Pancreas Collaborative (FPC) data, images, and/or biospecimens will need to submit a written proposal to the FPC biobank utilization committee. Decisions will be based on scientific merit, specimen availability, experience of the requesting investigator, and resources to conduct proposed methods. De-identified samples and/or data will be released if the concept receives approval and after scientific review committee and IRB approval is obtained, conflict of interests are checked, and a material transfer agreement is established. Intellectual property issues will need to be agreed upon. If access is granted, the biobank utilization committee may monitor the Investigator's Research studies to ensure appropriate use of the biospecimens and/or data. The Investigator shall provide a written summary of their research findings and reference this funding source in future manuscripts and presentations.
Related trials for Pancreatic Cancer
RecruitingPhase 3
HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer
KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting
RecruitingObservational study
Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
Colorectal Neoplasms, Gastric Neoplasms
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
Active, not recruitingPhase 3
Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors
Functioning Pancreatic Neuroendocrine Tumor, Intermediate Grade Lung Neuroendocrine Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Permuth, PhD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Cancer Cachexia, run by H. Lee Moffitt Cancer Center and Research Institute at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of Precachexia (time frame: Up to 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.