Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT00900523 |
Recruitment Status
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Completed
First Posted
: May 12, 2009
Last Update Posted
: April 18, 2013
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Tracking Information | ||||
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First Submitted Date | May 9, 2009 | |||
First Posted Date | May 12, 2009 | |||
Last Update Posted Date | April 18, 2013 | |||
Study Start Date | November 2006 | |||
Actual Primary Completion Date | July 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Prostaglandin E2 metabolite (PGE-M) levels in 24-hour urine samples [ Time Frame: Pre-surgical or chemotherapeutic treatment, over a 24-hour duration ] Patients will be collect their urine for 24 hours before they undergo any surgery or chemotherapy. Researchers will measure the amount of PGE-M in the urine.
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Original Primary Outcome Measures |
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Change History | Complete list of historical versions of study NCT00900523 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer | |||
Official Title | Urine Prostaglandin-M(PGE-M) in Ovarian Cancer | |||
Brief Summary | RATIONALE: Measuring the amount of prostaglandin metabolite in urine samples and studying tissue samples in the laboratory from patients with ovarian cancer may help doctors identify and learn more about biomarkers related to ovarian cancer and may help the study of cancer in the future. PURPOSE: This laboratory study is measuring the amount of prostaglandin metabolite in urine samples from patients with ovarian cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a pilot study. Patients submit 24-hour urine specimens prior to surgery for evaluation of urinary levels of prostaglandin E_2 metabolite (PGE-M). Patients also undergo assessment of tissue obtained at the time of surgery, including ovarian tumor tissue, normal surface ovarian epithelium tissue (if available), and fixed tissue embedded in a paraffin block. Tissue samples are analyzed by western blot and IHC for cyclooxygenase-1 and cyclooxygenase-2 expression. |
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Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Women with known or suspected ovarian cancer who are greater than 17 years in age. | |||
Condition | Ovarian Cancer | |||
Intervention |
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Study Groups/Cohorts | Known or suspected ovarian cancer
Women who have a diagnosis of ovarian cancer or who are suspected of having ovarian cancer
Interventions:
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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 |
7 | |||
Original Estimated Enrollment |
10 | |||
Actual Study Completion Date | July 2008 | |||
Actual Primary Completion Date | July 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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Ages | 17 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00900523 | |||
Other Study ID Numbers | VICC GYN 0648 VU-VICC-GYN-0648 VU-VICC-IRB-060680 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Marta Crispens, MD, Vanderbilt-Ingram Cancer Center | |||
Study Sponsor | Vanderbilt-Ingram Cancer Center | |||
Collaborators | National Cancer Institute (NCI) | |||
Investigators |
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PRS Account | Vanderbilt-Ingram Cancer Center | |||
Verification Date | April 2013 |