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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. Identifier: NCT00900523
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : April 18, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Marta Crispens, MD, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment
Ovarian Cancer Genetic: protein expression analysis Other: immunohistochemistry

Detailed Description:


  • 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.

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

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 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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.


  • No concurrent chronic use of steroids or NSAIDs

Information from the National Library of Medicine

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 identifier (NCT number): NCT00900523

Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Marta Crispens, MD Vanderbilt-Ingram Cancer Center

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Responsible Party: Marta Crispens, MD, Associate Professor; Gynecological Oncologist, Vanderbilt-Ingram Cancer Center Identifier: NCT00900523     History of Changes
Other Study ID Numbers: VICC GYN 0648
First Posted: May 12, 2009    Key Record Dates
Last Update Posted: April 18, 2013
Last Verified: April 2013
Keywords provided by Marta Crispens, MD, 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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders