Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass
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|ClinicalTrials.gov Identifier: NCT00238342|
Recruitment Status : Unknown
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : October 13, 2005
Last Update Posted : February 9, 2010
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 or disease||Intervention/treatment||Phase|
|Fallopian Tube Cancer Ovarian Cancer||Genetic: proteomic profiling Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry Procedure: biopsy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Official Title:||Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis|
|Study Start Date :||October 2005|
|Estimated Primary Completion Date :||October 2007|
- Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238342
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|Study Chair:||Elise C. Kohn, MD||NCI - Medical Oncology Branch|
|OverallOfficial:||Samir N. Khleif, MD||National Cancer Institute (NCI)|
|OverallOfficial:||Larry J. Copeland, MD||Ohio State University Comprehensive Cancer Center|