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

• ClinicalTrials.gov Identifier: NCT00984919
• Recruitment Status: Completed
• First Posted: September 25, 2009
• Last Update Posted: February 15, 2016
• Sponsor: Barbara Ann Karmanos Cancer Institute
• 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
• 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

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

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