Longitudinal Pancreatic Cancer Study
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT02250638
- Lead Sponsor
- Fujirebio Diagnostics, Inc.
- Brief Summary
To obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of pancreatic cancer.
- Detailed Description
The study objectives are described below:
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 140
- Males and females, age≥ 18 years
- 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
- Males and females, age <18 years
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer 3 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Harry & Jeanette Weinberg Cancer Institute
🇺🇸Baltimore, Maryland, United States
GI Research Institute
🇨🇦Vancouver, British Columbia, Canada
The Ohio State University
🇺🇸Columbus, Ohio, United States
Kansas City VA Center
🇺🇸Kansas City, Missouri, United States
Boca Raton Regional Hospital
🇺🇸Boca Raton, Florida, United States
Broward Health Medical Center
🇺🇸Fort Lauderdale, Florida, United States
New Hanover Regional Medical Center
🇺🇸Wilmington, North Carolina, United States