Proteomic Profiling in Diagnosing Ovarian Cancer in Patients Who Are Undergoing Surgery for an Abnormal Pelvic Mass

Not Applicable

• Conditions: Ovarian Cancer; Fallopian Tube Cancer

• Registration Number: NCT00238342
• Lead Sponsor: Gynecologic Oncology Group

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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.

Tertiary

* 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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-12
• Study First Posted: 2005-10-13
• Status Verified: 2007-04
• Primary Completion: 2007-10
• Last Update Submitted: 2010-02-06
• Last Update Posted: 2010-02-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)

Trial Locations

Locations (107)

Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham; 🇺🇸 Birmingham, Alabama, United States

Highlands Oncology Group - Fayetteville; 🇺🇸 Fayetteville, Arkansas, United States

Washington Regional Medical Center; 🇺🇸 Fayetteville, Arkansas, United States

Providence Saint Joseph Medical Center - Burbank; 🇺🇸 Burbank, California, United States

Kaiser Permanente Medical Center - Los Angeles; 🇺🇸 Los Angeles, California, United States

Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Jonsson Comprehensive Cancer Center at UCLA; 🇺🇸 Los Angeles, California, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center; 🇺🇸 Orange, California, United States

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus; 🇺🇸 New Britain, Connecticut, United States

Beebe Medical Center; 🇺🇸 Lewes, Delaware, United States

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