Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer

Tracking Information
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; (submitted: April 17, 2013)	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.
Original Primary Outcome Measures; (submitted: May 9, 2009)	Prostaglandin E2 metabolite (PGE-M) levels in 24-hour urine samples; Cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) expression in malignant and nonmalignant ovarian tissue as measured by western blot and IHC; Correlation of urine PGE-M levels with tissue COX-1 and COX-2 levels
Change History	Complete list of historical versions of study NCT00900523 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: April 17, 2013)	COX-1 and COX-2 expression in ovarian tumor tissue and non-malignant tissue [ Time Frame: Day of surgery ]COX-1 and COX-2 expression will be measured in samples of patients' malignant ovarian samples and matched non-malignant samples (the latter if available).; Correlation of urine PGE-M levels with tissue COX-1 and COX-2 levels [ Time Frame: After patients' surgery ]Patients' levels of urine PGE-M will be compared and contrasted with their levels of COX-1 and COX-2 in ovarian tumor tissue
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.
Detailed Description	OBJECTIVES: Determine the level of prostaglandin E_2 metabolite (PGE-M) in 24-hour urine samples collected prior to surgery or chemotherapy from patients with ovarian cancer.; Determine cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) expression by western blot and immunohistochemistry (IHC) in ovarian tumor tissue samples and matched normal ovarian tissue samples, if available, from these patients.; Correlate urine PGE-M levels with corresponding tissue COX-1 and COX-2 levels in urine and tissue samples from these patients. 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.
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
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	Genetic: protein expression analysis protein expression analysis Other Name: protein expression analysis for PGE-M; Other: immunohistochemistry immunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels Other Name: immunohistochemistry staining methods
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: Genetic: protein expression analysis; Other: immunohistochemistry
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: October 20, 2010)	7
Original Estimated Enrollment; (submitted: May 9, 2009)	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: Diagnosis of known or suspected ovarian cancer; Age greater than 17 years Exclusion Criteria: Pregnant or nursing; Taking steroids or non-steroidal anti-inflammatory drugs (NSAIDs) on a regular basis. PRIOR CONCURRENT THERAPY: No concurrent chronic use of steroids or NSAIDs
Sex/Gender	Sexes Eligible for Study: Female
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
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	Principal Investigator: Marta Crispens, MD Vanderbilt-Ingram Cancer Center
PRS Account	Vanderbilt-Ingram Cancer Center
Verification Date	April 2013