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Integration of an Epidemiologic Questionnaire Into Gynecologic Oncology Group Trials: First Project, Protocol 210

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Endometrial Cancer

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Trial Information

Integration of an Epidemiologic Questionnaire Into Gynecologic Oncology Group Trials: First Project, Protocol 210

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.


- 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.

Type of Study:


Study Design:


Principal Investigator

Louise Brinton, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Endometrial Cancer
  • Epidemiology
  • Questionnaire
  • Etiology
  • Biomarkers
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



GOG (Gynecologic Oncology Group) Tissue BankColumbus, Ohio