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Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Marta Crispens, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00900523
First received: May 9, 2009
Last updated: April 17, 2013
Last verified: April 2013
History of Changes

May 9, 2009
April 17, 2013
November 2006
July 2007   (final data collection date for primary outcome measure)
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.
  • Correlation of urine PGE-M levels with tissue COX-1 and COX-2 levels [ Designated as safety issue: No ]
  • Prostaglandin E2 metabolite (PGE-M) levels in 24-hour urine samples [ Designated as safety issue: No ]
  • Cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) expression in malignant and nonmalignant ovarian tissue as measured by western blot and IHC [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00900523 on ClinicalTrials.gov Archive Site
  • 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
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Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Women with known or suspected ovarian cancer who are greater than 17 years in age.
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
Known or suspected ovarian cancer
Women who have a diagnosis of ovarian cancer or who are suspected of having ovarian cancer
Interventions:
  • Genetic: protein expression analysis
  • Other: immunohistochemistry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
July 2008
July 2007   (final data collection date for primary outcome measure)

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
Female
17 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00900523
VICC GYN 0648, VU-VICC-GYN-0648, VU-VICC-IRB-060680
Yes
Marta Crispens, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Marta Crispens, MD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP