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Tuesday, January 15, 2002, 12:00 p.m. EDT
North Carolina Women Sought for Clinical Study of Fibroids' Growth
North Carolina women with uterine fibroids are being recruited for a study of how these "benign" tumors change and grow - and how symptoms such as pain and bleeding may be linked to these changes.
"With each woman getting four 20-minute MRI scans and a series of questionnaires over the course of a year, we'll be able to define how these tumors grow and what triggers growth," said Barbara J. Davis, chief of the Laboratory of Women's Health at the National Institute of Environmental Health Sciences (http://www.niehs.nih.gov) in Research Triangle Park, N.C., in announcing the $1.5 million clinical study. "We'll look at whether fibroid size can be associated with symptoms," Dr. Davis continued, "and we'll see if we can develop a scale that helps doctors suggest appropriate treatments for various stage tumors."
In a recent study by NIEHS among women in a Washington, D.C., health maintenance organization, ultrasound showed fibroids in 72 percent of African-American women, compared to 50 percent among Caucasian women. As a result, half of the 300 women being recruited for the North Carolina study will be African-American, and the National Center on Minority Health and Health Disparities (http://ncmhd.nih.gov/) is co-funding the new study.
The center and NIEHS are both parts of the federal National Institutes of Health (http://www.nih.gov) .
Dr. Davis said fibroids are called benign tumors because they are not cancerous, but that they don't seem so "benign" to women experiencing heavy bleeding or extreme pain. These symptoms and other complications are the primary reason for 700,000 hysterectomies (surgical removal of the uterus) a year in the United States, where it is the most performed gynecological operation.
Women interested in participating should have their primary doctors refer them to the study through physicians at the Duke University Medical Center Department of Reproductive Endocrinology (http://fertility.mc.duke.edu/) ( David Walmer, M.D., Ph.D.) in Durham or the University of North Carolina School of Medicine Department of Obstetrics and Gynecology (http://www.med.unc.edu/obgyn/) (Bruce Lessey, M.D., Ph.D.) in Chapel Hill. The women must be 18 to 48, have a fibroid about three inches in diameter or greater, or several fibroids that enlarge the uterus to the size it would ordinarily have at the fourth month of pregnancy.
The women will get a physical examination, must provide fasting urine and blood samples and respond to one long interview over the telephone and to short monthly updates. They will have magnetic resonance imaging (MRI) scans of the pelvic area at their first visit, and then at three, six and 12 months.
The women will be paid for their time, and they and their physicians will have access to their scans. They will not be asked to delay or change their therapy - and it is anticipated that perhaps 100 of the women will in the course of the year have hysterectomies or myomectomies (surgical removal of the fibroids.) In these cases, the women will be asked to donate the tissue removed for study.
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