Study Results
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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COMPLETED
140 participants
OBSERVATIONAL
2014-05-31
2021-06-30
Brief Summary
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Detailed Description
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1. Obtain serum and plasma specimens longitudinally collected from approximately 140 subjects diagnosed with pancreatic cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 19-9 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
2. To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 19-9 assays, for monitoring the course of disease and therapy in subjects diagnosed with pancreatic cancer.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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CA 19-9 Assay
Physicians use the CA 19-9 test results to manage their patients
Eligibility Criteria
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Inclusion Criteria
* Histologic/pathologic confirmation of exocrine pancreatic cancer
* Any stage of disease: Newly diagnosed, stable, disease progression
* Any treatment time point: Treatment naïve, currently receiving or completed therapy for pancreatic cancer including active monitoring.
* Individuals with a history of malignant disease other than pancreatic cancer that was resected greater than 5 years ago and are currently in remission are eligible.
* Life expectancy greater than 6 months
* Able to understand and willing to provide informed consent
Exclusion Criteria
* No histologic/pathologic confirmation of exocrine pancreatic cancer
* Life expectancy less than 6 months
* Any concurrent malignancy other than basal or squamous cell skin cancers or in-situ cervical cancer.
* Unable to provide informed consent
18 Years
ALL
No
Sponsors
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Fujirebio Diagnostics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Diana Dickson
Role: STUDY_DIRECTOR
Fujirebio Diagnostics, Inc.
Locations
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Boca Raton Regional Hospital
Boca Raton, Florida, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Harry & Jeanette Weinberg Cancer Institute
Baltimore, Maryland, United States
Kansas City VA Center
Kansas City, Missouri, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
GI Research Institute
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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FDI-68
Identifier Type: -
Identifier Source: org_study_id
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