Molecular Staging of Endometrial Cancer

GOG-210 is a molecular and surgico-pathological staging study of endometrial carcinoma. The overall goal of this pilot protocol is to improve outcome and/or quality of life for patients with endometrial cancer. This fundamental goal will be accomplished through the development of more accurate models of risk, identification of candidate targets for therapeutic intervention and utilization of individualized treatments based on molecular characteristics identified in tumor tissue, normal tissue and/or in readily accessible biological fluids, like serum and urine. This molecular and surgico-pathological staging study is structured to collect tissue, urine, serum, and epidemiologic and clinical data from approximately 3,500 patients with endometrial cancer identified at participating GOG institutions. All of the patients will be surgically-pathologically staged, consistently evaluated, further treated as needed, and followed for up to 10 years after surgery to document further treatment and outcome. A series of independent and integrated research projects will be undertaken to utilize high-throughput methodologies (e.g., genomics and proteomics) and more traditional techniques (e.g., immunoassays) to examine cellular and extracellular factors, including chromosomes, DNA, RNA, proteins, lipids and carbohydrates. The results obtained from the comprehensive laboratory testing performed on these clinical specimens with the clinical and epidemiologic data collected for each GOG-0210 patient will represent an enduring resource for endometrial cancer research to study the factors that control the growth and spread of endometrial cancer, and how to predict response to therapy and risk of disease spread, recurrence and overall survival for patients with this disease. This will be the first implementation of the NCI-developed epidemiologic questionnaire, which will allow GOG protocols to systematically and uniformly collect demographic and epidemiologic data that will enhance the analytic capabilities of this study. If successful, this study will serve as a model for other protocol to implement the same epidemiologic questionnaire.

• INCLUSION CRITERIA:
• Patients with endometrial carcinoma diagnosed by an endometrial biopsy or dilation and curettage who will undergo full surgical staging; all stages, grades and histologic subtypes will be eligible.
• Patients must be suitable candidates for surgery. Patients may also be entered on GOG-2222 (LAP2).
• Patients who have signed an approved Informed Consent.
• Patients who have met the pre-entry requirements specified in the Study Parameters.
• Patients with a prior malignancy (at least 5 years since diagnosis) with no current evidence of disease.

Exclusion criteria

• Patients not considered suitable candidates for surgery.
• Patients who have had prior retroperitoneal surgery.
• Patients who have received prior pelvic or abdominal radiation therapy.
• Patients who are pregnant.