Longitudinal Pancreatic Cancer Study

Fujirebio Diagnostics

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Other: CA 19-9 Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT02250638

FDI-68

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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