Trial Information

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

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.