Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer

NCT ID: NCT00900523

Last Updated: 2013-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Known or suspected ovarian cancer

Women who have a diagnosis of ovarian cancer or who are suspected of having ovarian cancer

protein expression analysis

Intervention Type GENETIC

protein expression analysis

immunohistochemistry

Intervention Type OTHER

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

Interventions

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protein expression analysis

protein expression analysis

Intervention Type GENETIC

immunohistochemistry

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

Intervention Type OTHER

Other Intervention Names

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protein expression analysis for PGE-M immunohistochemistry staining methods

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Marta Crispens, MD

Associate Professor; Gynecological Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marta Crispens, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Other Identifiers

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VU-VICC-GYN-0648

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-IRB-060680

Identifier Type: -

Identifier Source: secondary_id

VICC GYN 0648

Identifier Type: -

Identifier Source: org_study_id

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