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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elisabeth Heath, Barbara Ann Karmanos Cancer Institute Identifier:
First received: September 24, 2009
Last updated: February 12, 2016
Last verified: February 2016

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 Intervention
Prostate Cancer Other: high performance liquid chromatography Other: laboratory biomarker analysis Other: mass spectrometry

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pilot Study of the Role of 11-dh-TXB2 in Prostate Cancer Screening and Diagnosis

Resource links provided by NLM:

Further study details as provided by Elisabeth Heath, Barbara Ann Karmanos Cancer Institute:

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

Enrollment: 10
Study Start Date: November 2009
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   40 Years to 120 Years   (Adult, Senior)
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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00984919

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)
Principal Investigator: Elisabeth I. Heath, MD Barbara Ann Karmanos Cancer Institute
  More Information

Responsible Party: Elisabeth Heath, Principal Investigator, Barbara Ann Karmanos Cancer Institute Identifier: NCT00984919     History of Changes
Other Study ID Numbers: CDR0000654093
P30CA022453 ( U.S. NIH Grant/Contract )
Study First Received: September 24, 2009
Last Updated: February 12, 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:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on September 21, 2017