Longitudinal Pancreatic Cancer Study

Pancreatic Cancer Clinical Trial

Official title:

A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients With Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250638
• Other study ID #: FDI-68
• Status: Completed
• Start date: May 2014
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2020
• Source: Fujirebio Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• CA 19-9 Assay
Physicians use the CA 19-9 test results to manage their patients

Locations

Country	Name	City	State
Canada	GI Research Institute	Vancouver	British Columbia
United States	Harry & Jeanette Weinberg Cancer Institute	Baltimore	Maryland
United States	Boca Raton Regional Hospital	Boca Raton	Florida
United States	The Ohio State University	Columbus	Ohio
United States	Broward Health Medical Center	Fort Lauderdale	Florida
United States	Kansas City VA Center	Kansas City	Missouri
United States	New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Fujirebio Diagnostics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer		3 years