Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Urine Prostaglandin-M(PGE-M) in Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900523
• Other study ID #: VICC GYN 0648
• Secondary ID: VU-VICC-GYN-0648
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: April 17, 2013
• Start date: November 2006
• Est. completion date: July 2008

Study information

• Verified date: April 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 17 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Genetic:
• protein expression analysis
protein expression analysis

Other:
• immunohistochemistry
immunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostaglandin E2 metabolite (PGE-M) levels in 24-hour urine samples	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.	Pre-surgical or chemotherapeutic treatment, over a 24-hour duration	No
Secondary	COX-1 and COX-2 expression in ovarian tumor tissue and non-malignant tissue	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).	Day of surgery	No
Secondary	Correlation of urine PGE-M levels with tissue COX-1 and COX-2 levels	Patients' levels of urine PGE-M will be compared and contrasted with their levels of COX-1 and COX-2 in ovarian tumor tissue	After patients' surgery	No