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| Tracking Information | |||||
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| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | May 8, 2009 | ||||
| Start Date ICMJE | June 2000 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00020033 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Protein Evaluation in Patients With Stage III or Stage IV Primary Peritoneal or Fallopian Tube Cancer or Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer in Remission | ||||
| Official Title ICMJE | A Pilot Study of Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile Associated With Relapse | ||||
| Brief Summary | RATIONALE: The presence of specific proteins may allow a doctor to determine whether or not cancer has relapsed. PURPOSE: This laboratory study is studying how well protein evaluation predicts disease relapse in patients with stage III or stage IV primary peritoneal or fallopian tube cancer or stage II, stage III, or stage IV ovarian epithelial cancer that is in remission. |
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| Detailed Description | OBJECTIVES:
OUTLINE: Patients undergo history, physical examination with pelvic examination, laboratory evaluation, and noninvasive imaging at baseline, 1 month, 3 months, and every 3 months thereafter. Samples are analyzed by surface enhanced laser desorption ionization spectrometry to identify protein profiles. Samples are also analyzed for lysophosphatidic acid. Patient evaluation continues until biopsy proven relapse. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | Mehta AI, Ross S, Lowenthal MS, Fusaro V, Fishman DA, Petricoin EF 3rd, Liotta LA. Biomarker amplification by serum carrier protein binding. Dis Markers. 2003-2004;19(1):1-10. | ||||
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* 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 ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00020033 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000067598, NCI-00-C-0018 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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