Ovarian CancerNCT00900523
Prostaglandin Metabolite in Urine Samples From Patients With Ovarian Cancer
An observational study of Ovarian Cancer, run by Vanderbilt-Ingram Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- protein expression analysis and immunohistochemistry
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women with known or suspected ovarian cancer who are greater than 17 years in age.
Who may be able to join
- Diagnosis of known or suspected ovarian cancer
- Age greater than 17 years
Who cannot join
- 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
About this study
Official title: 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.
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.
- Conditions
- Ovarian Cancer
- Being tested
- protein expression analysis, immunohistochemistry
- 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
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein expression analysisGenetic
Also called protein expression analysis for PGE-M
protein expression analysis
immunohistochemistryOther
Also called immunohistochemistry staining methods
immunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels
| Study group | Role | What they receive |
|---|---|---|
| Known or suspected ovarian cancer | Women who have a diagnosis of ovarian cancer or who are suspected of having ovarian cancer Receives: Genetic: protein expression analysis; Other: immunohistochemistry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-surgical or chemotherapeutic treatment, over a 24-hour duration
Secondary outcomes (2)
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).
Measured: Day of surgery
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
Measured: After patients' surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startNov 2006
- Primary completionJul 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Marta Crispens, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Marta Crispens, MD, Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900523
- Sponsor's protocol ID
- VICC GYN 0648
- Other IDs
- VU-VICC-GYN-0648, VU-VICC-IRB-060680
- Status last verified
- Apr 2013
- First submitted
- 9 May 2009
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Prostaglandin-M(PGE-M) in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00900523
- Acronym / sponsor ID
- VICC GYN 0648
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Known or suspected ovarian cancer | – | Genetic: protein expression analysis, Other: immunohistochemistryWomen who have a diagnosis of ovarian cancer or who are suspected of having ovarian cancer |
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women with known or suspected ovarian cancer who are greater than 17 years in age.
Key inclusion criteria (2 listed)
- Diagnosis of known or suspected ovarian cancer
- Age greater than 17 years
Key exclusion criteria (4 listed)
- Pregnant or nursing
- Taking steroids or non-steroidal anti-inflammatory drugs (NSAIDs) on a regular basis.
- No concurrent chronic use of steroids or NSAIDs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein expression analysisAlso: protein expression analysis for PGE-Mprotein expression analysis | Genetic | Known or suspected ovarian cancer |
| immunohistochemistryAlso: immunohistochemistry staining methodsimmunohistochemical staining of tumor tissue to measure COX-1 and COX-2 levels | Other | Known or suspected ovarian cancer |
Primary outcome
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.
2 secondary outcomes
COX-1 and COX-2 expression in ovarian tumor tissue and non-malignant tissue
Time frame: Day of surgery
Correlation of urine PGE-M levels with tissue COX-1 and COX-2 levels
Time frame: After patients' surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta Crispens, MD principal investigator
Vanderbilt-Ingram Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Vanderbilt-Ingram Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2013.