Longitudinal Pancreatic Cancer Study
A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients With Pancreatic Cancer
1 other identifier
observational
140
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2014
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 24, 2014
CompletedFirst Posted
Study publicly available on registry
September 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 17, 2021
July 1, 2020
7.2 years
September 24, 2014
August 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer
3 years
Interventions
Physicians use the CA 19-9 test results to manage their patients
Eligibility Criteria
Approximately 140 subjects will be enrolled in this study. Women and men greater than or equal to 18 years of age with a histologically/pathologically confirmed diagnosis of pancreatic cancer and a minimum of three serial blood draws collected at disease evaluation time points, as determined by the treating physician's standard of care, will be eligible.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Broward Health Medical Center
Fort Lauderdale, Florida, 33316, United States
Harry & Jeanette Weinberg Cancer Institute
Baltimore, Maryland, 21237, United States
Kansas City VA Center
Kansas City, Missouri, 64128, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402, United States
The Ohio State University
Columbus, Ohio, 43210, United States
GI Research Institute
Vancouver, British Columbia, V6Z2K5, Canada
Biospecimen
Serum and Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Diana Dickson
Fujirebio Diagnostics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2014
First Posted
September 26, 2014
Study Start
May 1, 2014
Primary Completion
June 30, 2021
Study Completion
June 30, 2021
Last Updated
August 17, 2021
Record last verified: 2020-07