Benign Reproductive Tissue Analysis for Endometrial Cancer Markers
Completed
Conditions studied: Oophorectomy for Benign Reasons, Hysterectomy
In brief
Background: * Endometrial cancer (cancer of the lining of the uterus) is the most common gynecologic cancer in the United States. * Currently, there are no markers (components of blood and tissue that determine who might be at risk for developing cancer) for endometrial cancer. Objectives: -To see if women who are undergoing hysterectomy are willing to provide blood and tissue samples to help doctors identify markers that would indicate increased risk for developing endometrial cancer. Eligibility: -Women between 35 and 54 years of age who will undergo hysterectomy for a non-cancerous condition, such as uterine fibroids, uterine prolapse, abnormal uterine bleeding, and others at Magee-Women's Hospital in Pittsburgh, Penn. Design: * Patients' medical records are reviewed and patients complete a questionnaire including information on race and ethnic background, education, marital status, family history, height, weight, pregnancy history, smoking history, medication history, history about menstrual periods and menopausal symptoms. * Patients provide blood and urine samples before surgery. * A sample of fat tissue is removed during surgery in patients undergoing abdominal surgery. * Tissue samples from the removed uterus (and ovaries if the ovaries are also removed) are collected and analyzed for markers for endometrial cancer.
Key facts
- Study ID
- NCT00481754
- Run by
- National Cancer Institute (NCI)
- People needed
- 359
- Starts
- 2006-04-24
- Expected to finish
- 2020-11-13
- Last updated by the study team
- 2020-11-17
Who can join
Age: 18 and older, up to 54. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- Evidence on gross examination of the surgically removed uterus that there is a carcinoma invading the myometrium; however, post-operative diagnosis of early endometrial carcinoma will not be a cause for post-hoc exclusion after specimen and data collection. We will exclude women with a previous gynecologic or gastrointestinal cancer. At the discretion of the surgeon, we will exclude women with cancer in whom the study procedures may interfere with clinical management (e.g. staging of the cancer). We will exclude women who had neo-adjuvant chemotherapy and women who underwent chemoprevention of ovarian or breast cancer. We will also exclude women currently wearing an intrauterine device.
Where it is running
- Magee Women's hospital — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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