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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03851133




Registration number
NCT03851133
Ethics application status
Date submitted
12/02/2019
Date registered
22/02/2019

Titles & IDs
Public title
Florida Pancreas Collaborative Next Generation Biobank
Scientific title
The Florida Pancreas Collaborative Next-Generation Biobank: Reducing Health Disparities and Improving Survival for Pancreatic Cancer
Secondary ID [1] 0 0
8JK02
Secondary ID [2] 0 0
MCC-19717
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cancer 0 0
Cancer Cachexia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Pancreatic
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Blood Sample Collection
Other interventions - Tumor Sample collection
Other interventions - Data Collection

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


Other interventions: 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 interventions: 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 interventions: 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evidence of Precachexia
Timepoint [1] 0 0
Up to 12 months
Primary outcome [2] 0 0
Evidence of Cachexia
Timepoint [2] 0 0
Up to 12 months
Primary outcome [3] 0 0
Evidence of Refractory Cachexia
Timepoint [3] 0 0
Up to 12 months
Primary outcome [4] 0 0
Presence of Myopenia
Timepoint [4] 0 0
Up to 12 months
Primary outcome [5] 0 0
Presence of Visceral Adiposity
Timepoint [5] 0 0
Up to 12 months
Secondary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Progression Free Survival
Timepoint [2] 0 0
Up to 24 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/07/2025
Actual
Sample size
Target
Accrual to date
Final
500
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Other
Name
H. Lee Moffitt Cancer Center and Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Permuth, PhD
Address 0 0
H. Lee Moffitt Cancer Center and Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
Will be available approximately one year after study ends, approximately September 2022. End of availability undetermined at this time.
Available to whom?
Data and specimens will be shared with researchers interested in this topic area who wish to pursue analyses that may be descriptive, analytic, molecular, or correlative in nature. The access criteria used to share IPD and any additional supporting information will involve a formal process which involves submitting 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. 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 (COI) are checked, a material transfer agreement is established between institutions, and intellectual property issues are agreed upon. The release of data will be based on the nature of the request and can represent aggregate or individual-level data.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03851133