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
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.
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
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
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.
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.
Elise C Kohn, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|
|Cedars Sinai Medical Center||Los Angeles, California 90048-1804|
|Fox Chase Cancer Center||Philadelphia, Pennsylvania 19111|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Duke University||Durham, North Carolina 27710|
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|
|New York University School of Medicine||New York, New York 10016|
|Evanston Northwestern University Hospital||Evanston, Illinois|
|University of Washington/Fred Hutchinson Cancer Research Center||Seattle, Washington 28104|