Plasma and Urine Samples From Patients With Hormone-Refractory Prostate Cancer Enrolled on Clinical Trials CALGB-9480 or CALGB-9583
NCT ID: NCT00898833
Last Updated: 2017-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
868 participants
OBSERVATIONAL
2003-07-31
2016-06-30
Brief Summary
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PURPOSE: This laboratory study is measuring plasma and urine biomarkers in patients with advanced prostate cancer that did not respond to hormone therapy.
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Detailed Description
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Primary
* Correlate plasma and urine vascular endothelial growth factor (VEGF) levels with survival duration in patients with advanced hormone-refractory adenocarcinoma of the prostate previously enrolled on CALGB-9480.
* Determine whether plasma chromogranin A (CgA) and plasma interleukin-6 (IL-6) levels predict survival duration in these patients.
* Determine whether plasma human Kallikrein 2 (hK2) levels are prognostic for overall survival of these patients.
Secondary
* Determine the prognostic significance of plasma and urine VEGF levels, plasma CgA levels, plasma IL-6 levels, and plasma hK2 levels in relation to overall survival of these patients.
* Correlate plasma VEGF levels with urine VEGF levels in these patients.
* Correlate plasma CgA levels with previously measured serum prostate-specific antigen (PSA) and plasma VEGF levels in these patients.
* Correlate plasma hK2 levels with PSA changes after treatment with suramin to determine if hK2 may have predictive value, independent or additive to measures of disease response in these patients.
* Correlate plasma hK2 levels with PSA levels in these patients.
OUTLINE: Plasma from patients is collected for measurement of the following biomarkers: vascular endothelial growth factor (VEGF), chromogranin A, interleukin-6, and human Kallikrein 2. Urine is collected for VEGF measurement.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group 1
Previously collected plasma and urine samples are analyzed for VEGF via ELISA, plasma samples are analyzed for CgA and IL-6 via ELISA, hK2 via immunometric assay, plasma samples are analyzed for PSA via Tandem-R PSA kit, plasma samples are analyzed for TNF-alpha, sTNF-R1, and IL-8 via quantikine IL-8 immunoassay.
laboratory biomarker analysis
Interventions
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laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Samples collected and shipped appropriately
* Institutional Review Board (IRB) review and approval at the institution where the laboratory work will be performed is required
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Mary Ellen Taplin, MD
Role: STUDY_CHAIR
Dana-Farber Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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CALGB-150201
Identifier Type: -
Identifier Source: secondary_id
CDR0000321397
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-150201
Identifier Type: -
Identifier Source: org_study_id
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