Longitudinal Pancreatic Cancer Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02250638

Enrollment

140

Registered

2014-09-26

Start date

2014-05-31

Completion date

2021-06-30

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

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.

Interventions

OTHERCA 19-9 Assay

Physicians use the CA 19-9 test results to manage their patients

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026