Biomarker 11-dh-TXB2 in Blood and Urine Samples From Patients With Prostate Cancer and Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00984919 |
Recruitment Status :
Completed
First Posted : September 25, 2009
Last Update Posted : February 15, 2016
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Tracking Information | ||||
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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 |
Identification of 11-dh-TXB2 in the blood and urine [ Time Frame: 2 to 4 months ] | |||
Original Primary Outcome Measures |
Identification of 11-dh-TXB2 in the blood and urine | |||
Change History | ||||
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. |
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Detailed Description | OBJECTIVES:
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 | |||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Cancer clinic | |||
Condition | Prostate Cancer | |||
Intervention |
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Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
10 | |||
Original Estimated Enrollment |
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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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 | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00984919 | |||
Other Study ID Numbers | CDR0000654093 P30CA022453 ( U.S. NIH Grant/Contract ) WSU-2009-058 |
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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 |
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PRS Account | Barbara Ann Karmanos Cancer Institute | |||
Verification Date | February 2016 |