A Multi-Institutional Study of Proteomic Evaluation of Epithelial Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer Patients in First Clinical Remission: Development of a Protein Fingerprint Profile of Relapse

Background: Over 80% of patients with advanced stage epithelial ovarian cancer will relapse Serum biomarkers are needed for predictors of persistent disease and relapse CA-125 is a less than satisfactory clinical tool for detecting relapse A serum repository of samples from women with ovarian cancer is needed to develop and validate the multiple tests being created for ovarian cancer recurrence and screening. Objectives: To create a multi-institutional repository from which investigations of serum proteomic signature profiles of epithelial ovarian cancer and relapse will be developed and validated To determine the sensitivity and specificity of the proteomic signature profiles for relapse To compare the accuracy of proteomic evaluation and CA125 in classifying patient disease progression To identify the temporal relationship between a rise in CA125 value versus the development of proteomic signature profiles of relapse. To detect the impact of study participation on quality of life. To collect epidemiological data for patients in the target population Eligibility: Patients in first remission from treatment of FIGO stage III/IV primary peritoneal, fallopian tube, or epithelial ovarian carcinoma as defined by normal CA125, no evidence of disease on abdominopelvic CT scan, and normal post-hysterectomy physical exam. Entry within 12 weeks of last administration of chemotherapy. S/P surgical debulking and completion of primary therapy with platinum/taxane-containing chemotherapy of no more than a total of 8 cycles. Laboratory evidence of good end organ function. Design: Phase of Trial: Biomarker/Laboratory Analysis. Number of patients to be enrolled: 400 Planned statistical analysis for primary endpoint: Training set to include 100 women, half of whom are in remission and half of whom have recurrent disease. Validation set will include 200 women, half of whom are in remission and half of whom have recurrent disease.