Overview

This trial is active, not recruiting.

Conditions fallopian tube cancer, ovarian cancer
Treatments proteomic profiling, surface-enhanced laser desorption/ionization-time of flight mass spectrometry, biopsy
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date October 2005
End date October 2007
Trial size 2000 participants
Trial identifier NCT00238342, CDR0000445437, GOG-0220

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose diagnostic

Primary Outcomes

Measure
Proteomic proflie (i.e. discrimination of tumor from nontumor in pelvic mass)
time frame:

Eligibility Criteria

Female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Abnormal pelvic mass by physical examination or imaging test - Undiagnosed - Planning to undergo surgical evaluation within the next 3 weeks PATIENT CHARACTERISTICS: Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Negative pregnancy test PRIOR CONCURRENT THERAPY: Surgery - See Disease Characteristics

Additional Information

Official title Pelvic Mass Study to Develop Serum Proteomic Profiles (SIGNATURES) for Epithelial Ovarian Cancer Diagnosis and Prognosis
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).