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Tracking Information | |||||||||||||
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First Received Date † | October 12, 2005 | ||||||||||||
Last Updated Date | February 6, 2009 | ||||||||||||
Start Date † | October 2005 | ||||||||||||
Current Primary Outcome Measures † |
Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass) [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00238342 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † | |||||||||||||
Original Secondary Outcome Measures † | |||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass | ||||||||||||
Official Title † | Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis | ||||||||||||
Brief Summary | RATIONALE: Finding specific proteins in the blood may help doctors tell whether a patient has ovarian cancer. PURPOSE: This clinical trial is studying how well proteomic profiling works in diagnosing ovarian cancer in patients who are undergoing surgery for an abnormal pelvic mass. |
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Detailed Description | OBJECTIVES: Primary
Secondary
Tertiary
OUTLINE: This is a pilot, two-part, multicenter study.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study. |
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Study Phase | |||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Diagnostic | ||||||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||||||||||
Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||
Estimated Enrollment † | 2000 | ||||||||||||
Completion Date | |||||||||||||
Estimated Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Surgery
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Gender | Female | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | United States | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00238342 | ||||||||||||
Responsible Party | |||||||||||||
Secondary IDs †† | GOG-0220 | ||||||||||||
Study Sponsor † | Gynecologic Oncology Group | ||||||||||||
Collaborators †† | National Cancer Institute (NCI) | ||||||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | April 2007 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |