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OpenTrials
Completed

NCT Number: NCT02250638

Longitudinal Pancreatic Cancer Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GI Research Institute, Vancouver, British Columbia, Canada

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About this study

The study objectives are described below:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CA 19-9 Assay

Other

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

Primary outcomes

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

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Fujirebio Diagnostics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2014
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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