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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elisabeth Heath, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00984919
First received: September 24, 2009
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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 Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Identification of 11-dh-TXB2 in the blood and urine [ Time Frame: 2 to 4 months ] [ Designated as safety issue: No ]

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:

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cancer clinic

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984919

Locations
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Principal Investigator: Elisabeth I. Heath, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Elisabeth Heath, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00984919     History of Changes
Other Study ID Numbers: CDR0000654093, P30CA022453, WSU-2009-058
Study First Received: September 24, 2009
Last Updated: January 14, 2014
Health Authority: United States: Federal Government

Keywords provided by 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
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 26, 2014