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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020033 |
RATIONALE: The presence of specific proteins may allow a doctor to determine whether or not cancer has relapsed.
PURPOSE: This clinical trial 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.
Condition | Intervention |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Procedure: diagnostic imaging Procedure: laboratory biomarker analysis Procedure: proteomic profiling Procedure: surface-enhanced laser desorption/ionization-time of flight mass spectrometry |
Study Type: | Observational |
Official Title: | A Pilot Study of Proteomic Evaluation of Epithelial Ovarian Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile Associated With Relapse |
Study Start Date: | June 2000 |
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed stage III or IV primary peritoneal, fallopian tube, or ovarian epithelial cancer, or stage IIC ovarian clear cell cystadenocarcinoma in first clinical remission as defined by:
Completion of standard platinum/paclitaxel or carboplatin/paclitaxel-based chemotherapy with complete response
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |
NCI - Center for Cancer Research | |
Bethesda, Maryland, United States, 20892-1906 | |
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Virginia Kwitkowski, MS, RN, CS, CRNP | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000067598, NCI-00-C-0018 |
Study First Received: | July 11, 2001 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00020033 |
Health Authority: | United States: Federal Government |
stage II ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
ovarian clear cell cystadenocarcinoma fallopian tube cancer peritoneal cavity cancer |
Ovarian cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms Fallopian Tube Neoplasms |
Dental Caries Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |