Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer

April 17, 2013 updated by: Marta Crispens, MD, Vanderbilt-Ingram Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

7

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women with known or suspected ovarian cancer who are greater than 17 years in age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • protein expression analysis for PGE-M
Other: immunohistochemistry
immunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels
Other Names:
  • immunohistochemistry staining methods

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-surgical or chemotherapeutic treatment, over a 24-hour duration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day of surgery
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
After patients' surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Marta Crispens, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

April 18, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC GYN 0648
  • VU-VICC-GYN-0648
  • VU-VICC-IRB-060680

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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