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Longitudinal Pancreatic Cancer Study

Sponsor
Fujirebio Diagnostics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02250638
Collaborator
(none)
140
Enrollment
7
Locations
86
Duration (Months)
20
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: CA 19-9 Assay

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
140 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients With Pancreatic Cancer
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Outcome Measures

Primary Outcome Measures

  1. A Prospective Longitudinal Study of CA 19-9 as an Aid in Monitoring Disease in Patients with Pancreatic Cancer [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boca Raton Regional Hospital Boca Raton Florida United States 33486
2 Broward Health Medical Center Fort Lauderdale Florida United States 33316
3 Harry & Jeanette Weinberg Cancer Institute Baltimore Maryland United States 21237
4 Kansas City VA Center Kansas City Missouri United States 64128
5 New Hanover Regional Medical Center Wilmington North Carolina United States 28402
6 The Ohio State University Columbus Ohio United States 43210
7 GI Research Institute Vancouver British Columbia Canada V6Z2K5

Sponsors and Collaborators

  • Fujirebio Diagnostics, Inc.

Investigators

  • Study Director: Diana Dickson, Fujirebio Diagnostics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fujirebio Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT02250638
Other Study ID Numbers:
  • FDI-68
First Posted:
Sep 26, 2014
Last Update Posted:
Aug 17, 2021
Last Verified:
Jul 1, 2020
Additional relevant MeSH terms:
Pancreatic Neoplasms

Study Results

No Results Posted as of Aug 17, 2021