Clinical trial NCT00900523: Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer
Official title: Urine Prostaglandin-M(PGE-M) in Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: recurrent ovarian epithelial cancer
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 7
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with known or suspected ovarian cancer who are greater than 17 years in age.

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.

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

Primary outcomes:
measure: Prostaglandin E2 metabolite (PGE-M) levels in 24-hour urine samples
timeFrame: Pre-surgical or chemotherapeutic treatment, over a 24-hour duration
Secondary outcomes:
measure: COX-1 and COX-2 expression in ovarian tumor tissue and non-malignant tissue
timeFrame: Day of surgery
measure: Correlation of urine PGE-M levels with tissue COX-1 and COX-2 levels
timeFrame: After patients' surgery
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Marta Crispens, MD
role: PRINCIPAL_INVESTIGATOR
References: