Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer
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Purpose
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 | Intervention |
|---|---|
|
Ovarian Cancer |
Genetic: protein expression analysis Other: immunohistochemistry |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Urine Prostaglandin-M(PGE-M) in Ovarian Cancer |
- Prostaglandin E2 metabolite (PGE-M) levels in 24-hour urine samples [ Time Frame: Pre-surgical or chemotherapeutic treatment, over a 24-hour duration ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Patients' levels of urine PGE-M will be compared and contrasted with their levels of COX-1 and COX-2 in ovarian tumor tissue
| Enrollment: | 7 |
| Study Start Date: | November 2006 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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-M
Other: immunohistochemistry
immunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels
Other Name: immunohistochemistry staining methods
|
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.
Eligibility| Ages Eligible for Study: | 17 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Women with known or suspected ovarian cancer who are greater than 17 years in age.
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Marta Crispens, MD, Associate Professor; Gynecological Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00900523 History of Changes |
| Other Study ID Numbers: | VICC GYN 0648, VU-VICC-GYN-0648, VU-VICC-IRB-060680 |
| Study First Received: | May 9, 2009 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
recurrent ovarian epithelial cancer stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
ClinicalTrials.gov processed this record on May 19, 2013