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CompletedNCT00900523Updated Apr 18, 2013

Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer

An observational study in Ovarian Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Completed. Open to female participants aged 17 Years and older. Per ClinicalTrials.gov, last updated 2013-04-18.

Sponsored by Vanderbilt-Ingram Cancer Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
7
Ages
17 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 7 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years and older
Sexes eligible
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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
7 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Other: immunohistochemistry

Interventions

  • Geneticprotein expression analysis

    protein expression analysis

    Also known as: protein expression analysis for PGE-M

  • Otherimmunohistochemistry

    immunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels

    Also known as: immunohistochemistry staining methods

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Pre-surgical or chemotherapeutic treatment, over a 24-hour duration

Secondary outcomes

  1. 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).

    Time frame: Day of surgery

  2. 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

    Time frame: After patients' surgery

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00900523
Lead sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Marta Crispens, MD (Associate Professor; Gynecological Oncologist, Vanderbilt-Ingram Cancer Center) — Principal investigator
First posted
May 12, 2009
Start date
Nov 2006
Primary completion
Jul 2007
Completion
Jul 2008
Last update
Apr 18, 2013

Study contacts

Marta Crispens, MD
principal investigator · Vanderbilt-Ingram Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

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