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Therapeutic Areas: Oncology
Disease Category: Endometrial Cancer

Trial Information

A Molecular Staging Study of Endometrial Carcinoma

The study, sponsored by the National Cancer Institute and the Gynecologic Oncology Group (GOG) will collect tissue samples from women with cancer of the endometrium (lining of the uterus). Researchers will use the samples to learn more about endometrial cancer and develop new treatments and methods of prevention. Before surgery, patients will complete a 20-minute questionnaire that includes questions about their background, reproductive history, menstruation and menopause, certain surgeries, birth control pills and hormone replacement therapy, other drugs and medicines, weight and height, smoking, medical history and family history of cancer.

Some of the tissue removed during surgery, plus a urine sample collected from a catheter bag during surgery, and blood drawn before surgery and at follow-up visits 6 weeks and 3 years after surgery will be sent to the GOG Tissue Bank in Columbus, Ohio.

Patients will have follow-up visits 6 weeks after surgery, then every 6 months for the next 2 years, followed annually for the next 7 years, for a total 10-year follow-up. The visits will include an examination and questions about health status and treatments received between visits.

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.
• Patient 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 lease 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.

Mark Einstein, MD, Principal Investigator/ Lorraine Centrilla, RN, Research Nurse
Einstein-Montefiore Institute for Clinical & Translational Research
Montefiore Medical Center
1695 Eastchester Road
Bronx, NY 10461
Phone: 718-405-8082
EMail: meinstei@montefiore.org

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