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Biomarker 11-dh-TXB2 in Blood and Urine Samples From Patients With Prostate Cancer and Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT00984919
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : February 15, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elisabeth Heath, Barbara Ann Karmanos Cancer Institute

Tracking Information
First Submitted Date September 24, 2009
First Posted Date September 25, 2009
Last Update Posted Date February 15, 2016
Study Start Date November 2009
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 11, 2013)
Identification of 11-dh-TXB2 in the blood and urine [ Time Frame: 2 to 4 months ]
Original Primary Outcome Measures
 (submitted: September 24, 2009)
Identification of 11-dh-TXB2 in the blood and urine
Change History Complete list of historical versions of study NCT00984919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarker 11-dh-TXB2 in Blood and Urine Samples From Patients With Prostate Cancer and Healthy Volunteers
Official Title Pilot Study of the Role of 11-dh-TXB2 in Prostate Cancer Screening and Diagnosis
Brief Summary

RATIONALE: Studying samples of blood and urine from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

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.

Detailed Description

OBJECTIVES:

  • 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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Cancer clinic
Condition Prostate Cancer
Intervention
  • Other: high performance liquid chromatography
  • Other: laboratory biomarker analysis
  • Other: mass spectrometry
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 11, 2013)
10
Original Estimated Enrollment
 (submitted: September 24, 2009)
80
Actual Study Completion Date February 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

DISEASE CHARACTERISTICS:

  • 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)
Sex/Gender
Sexes Eligible for Study: Male
Ages 40 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00984919
Other Study ID Numbers CDR0000654093
P30CA022453 ( U.S. NIH Grant/Contract )
WSU-2009-058
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
Study Sponsor Barbara Ann Karmanos Cancer Institute
Collaborators National Cancer Institute (NCI)
Investigators
Principal Investigator: Elisabeth I. Heath, MD Barbara Ann Karmanos Cancer Institute
PRS Account Barbara Ann Karmanos Cancer Institute
Verification Date February 2016