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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00238342 |
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.
Condition | Intervention |
---|---|
Fallopian Tube Cancer Ovarian Cancer |
Genetic: proteomic profiling Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry Procedure: biopsy |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis |
Estimated Enrollment: | 2000 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Abnormal pelvic mass by physical examination or imaging test
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Surgery
Study Chair: | Elise C. Kohn, MD | NCI - Medical Oncology Branch |
Investigator: | Samir N. Khleif, MD | National Cancer Institute (NCI) |
Investigator: | Larry J. Copeland, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
Study ID Numbers: | CDR0000445437, GOG-0220 |
Study First Received: | October 12, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00238342 History of Changes |
Health Authority: | United States: Federal Government |
stage I ovarian epithelial cancer stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer fallopian tube cancer |
ovarian clear cell cystadenocarcinoma ovarian endometrioid adenocarcinoma ovarian mucinous cystadenocarcinoma ovarian serous cystadenocarcinoma ovarian undifferentiated adenocarcinoma |
Cystadenocarcinoma, Serous Fallopian Tube Cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer |
Carcinoma, Endometrioid Fallopian Tube Neoplasms Fallopian Tube Diseases Genital Diseases, Female Ovarian Cancer Endocrinopathy Adenocarcinoma Endocrine Gland Neoplasms |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Fallopian Tube Neoplasms |
Adnexal Diseases Fallopian Tube Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Endocrine Gland Neoplasms |