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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00984919
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : February 15, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elisabeth Heath, Barbara Ann Karmanos Cancer Institute

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.

Condition or disease Intervention/treatment
Prostate Cancer Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study of the Role of 11-dh-TXB2 in Prostate Cancer Screening and Diagnosis
Study Start Date : November 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Identification of 11-dh-TXB2 in the blood and urine [ Time Frame: 2 to 4 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Cancer clinic


  • 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)


  • No clinical evidence of liver cirrhosis or chronic liver disease (i.e., evidence of ascites or severe coagulopathy)
  • No active prostatitis


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00984919

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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Elisabeth I. Heath, MD Barbara Ann Karmanos Cancer Institute

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Responsible Party: Elisabeth Heath, Principal Investigator, Barbara Ann Karmanos Cancer Institute Identifier: NCT00984919    
Other Study ID Numbers: CDR0000654093
P30CA022453 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: February 15, 2016
Last Verified: February 2016
Keywords provided by Elisabeth Heath, Barbara Ann Karmanos Cancer Institute:
recurrent prostate cancer
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases