NCT00238342

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

Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
GENETIC	proteomic profiling
OTHER	surface-enhanced laser desorption/ionization-time of flight mass spectrometry
PROCEDURE	biopsy

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-10-01
• First posted: 2005-10-13
• Last updated: 2010-02-09

Locations

107 sites across 1 country: United States