Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass
Recruitment status was Active, not recruiting
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.
Fallopian Tube Cancer
Genetic: proteomic profiling
Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
|Study Design:||Primary Purpose: Diagnostic|
|Official Title:||Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis|
- Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass) [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Estimated Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
- Generate and validate a serum proteomic profile that can predict the presence of invasive ovarian epithelial cancer using preoperative serum specimens obtained from patients undergoing surgical evaluation for an abnormal pelvic mass.
- Generate a proteomic profile that can distinguish early- from late-stage invasive ovarian epithelial cancer using preoperative serum specimens from patients who are subsequently diagnosed with invasive ovarian epithelial cancer.
- Determine whether serum proteomic profiling can predict the presence of postoperative residual disease in these patients.
- Determine whether serum proteomic profiling can predict prognosis in these patients.
OUTLINE: This is a pilot, two-part, multicenter study.
- Part A: Within 3 weeks prior to surgical evaluation, patients undergo collection of serum specimen for proteomic profiling using surface-enhanced or matrix-associated laser desorption ionization spectrometry-time of flight detection (SELDI/MALDI-TOF). Patients then undergo surgical evaluation (i.e., biopsy and/or resection) of the pelvic mass. Patients who are diagnosed with invasive ovarian epithelial adenocarcinoma or papillary serous fallopian tube carcinoma (no low malignant potential tumors) AND are without postoperative infection proceed to part B of the study.
- Part B: Patients undergo collection of postoperative serum specimen for proteomic profiling using SELDI/MALDI-TOF within 3-8 weeks after surgery, before starting chemotherapy, and at end of chemotherapy.
After completion of study procedures, patients are followed periodically for up to 10 years.
PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
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|Study Chair:||Elise C. Kohn, MD||NCI - Medical Oncology Branch|
|Investigator:||Samir N. Khleif, MD||National Cancer Institute (NCI)|
|Investigator:||Larry J. Copeland, MD||Ohio State University Comprehensive Cancer Center|