Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00900523|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : April 18, 2013
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.
|Condition or disease||Intervention/treatment|
|Ovarian Cancer||Genetic: protein expression analysis Other: immunohistochemistry|
- 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|
|Actual Enrollment :||7 participants|
|Official Title:||Urine Prostaglandin-M(PGE-M) in Ovarian Cancer|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2008|
Known or suspected ovarian cancer
Women who have a diagnosis of ovarian cancer or who are suspected of having ovarian cancer
Genetic: protein expression analysis
protein expression analysis
Other Name: protein expression analysis for PGE-MOther: immunohistochemistry
immunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels
Other Name: immunohistochemistry staining methods
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900523
|Principal Investigator:||Marta Crispens, MD||Vanderbilt-Ingram Cancer Center|