Clinical trial NCT02250638: Longitudinal Pancreatic Cancer Study
Official title: A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Fujirebio Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Baltimore
country: United States
facility: Harry & Jeanette Weinberg Cancer Institute
state: Maryland
city: Kansas City
country: United States
facility: Kansas City VA Center
state: Missouri
city: Wilmington
country: United States
facility: New Hanover Regional Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
Study officials:
affiliation: Fujirebio Diagnostics, Inc.
name: Diana Dickson
role: STUDY_DIRECTOR
References: