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

NCT00984919 | Completed DMC

• 3 other identifiers: CDR0000654093P30CA022453WSU-2009-058
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

• Identification of 11-dh-TXB2 in the blood and urine

  2 to 4 months

Interventions

high performance liquid chromatography OTHER

laboratory biomarker analysis OTHER

mass spectrometry OTHER

Eligibility Criteria

• Age: 40 Years - 120 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer clinic

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Chromatography, High Pressure Liquid; Mass Spectrometry

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Elisabeth I. Heath, MD

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: November 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 15, 2016

Record last verified: 2016-02

Locations

US (1)