Biomarker 11-dh-TXB2 in Blood and Urine Samples From Patients With Prostate Cancer and Healthy Volunteers
NCT ID: NCT00984919
Last Updated: 2016-02-15
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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COMPLETED
10 participants
OBSERVATIONAL
2009-11-30
2011-02-28
Brief Summary
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PURPOSE: This research study is looking at a biomarker, 11-dh-TXB2, in blood and urine samples from patients with prostate cancer and healthy volunteers.
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Detailed Description
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* To identify a potential novel marker of prostate cancer in the blood and urine, 11-dh-TXB2, to be used as a screening tool for prostate cancer as well as in detection of early relapse in patients previously treated for early-stage prostate cancer.
OUTLINE: Blood and urine samples are collected and analyzed for plasma and urinary 11-dh-TXB2 levels by HPLC and tandem-mass spectrometry.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Interventions
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high performance liquid chromatography
laboratory biomarker analysis
mass spectrometry
Eligibility Criteria
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Inclusion Criteria
* Meets one of the following criteria:
* Histopathologically confirmed prostate cancer meeting 1 of the following criteria:
* Newly diagnosed untreated disease
* Received prior local therapy (prostatectomy, definitive radiotherapy, brachytherapy, or cryotherapy) with no evidence of disease activity (defined as serum PSA \< 0.4 ng/mL post therapy) and by imaging studies
* Experienced biochemical failure (defined as rise in serum PSA ≥ 0.4 ng/mL post therapy)
* Healthy volunteer (clinic patient with no history of clinically significant malignancies within the past 6 months)
PATIENT CHARACTERISTICS:
* No clinical evidence of liver cirrhosis or chronic liver disease (i.e., evidence of ascites or severe coagulopathy)
* No active prostatitis
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 30 days since prior and no concurrent regular antiplatelet agents (including aspirin, anagrelide, cilastazole, clopidogrel, dipyridamole, pentoxiphylline, sulfinpyrazone, or ticlopidine)
* More than 7 days since prior and no concurrent NSAIDs (including ibuprofen, celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, indomethacin, ketoprofen, meclofenamate, mefenamic acid, nabumetone, naproxen, oxaprozin, piroxicam, sulindac, or tolmetin)
40 Years
120 Years
MALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Barbara Ann Karmanos Cancer Institute
OTHER
Responsible Party
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Elisabeth Heath
Principal Investigator
Principal Investigators
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Elisabeth I. Heath, MD
Role: PRINCIPAL_INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Countries
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Other Identifiers
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WSU-2009-058
Identifier Type: -
Identifier Source: secondary_id
CDR0000654093
Identifier Type: -
Identifier Source: org_study_id
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