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Mayo Clinic Examines a New Approach in Treating Women with Abnormal Pap Smears

Tuesday, October 29, 2002

ROCHESTER, Minn. — Mayo Clinic's Cancer Center seeks female volunteers who have been diagnosed with abnormal cells on the cervix. The purpose of this research study is to learn how well, if at all, imiquimod may work to prevent the growth of new cancers of the cervix. Imiquimod, also known as Aldara (registered trademark), is a cream that acts as a stimulator of the immune system. This research study will try to determine how well imiquimod works to prevent the recurrence of abnormal cells in the cervix.

Abnormal cells are collected and identified during a simple Pap test. This is the precancerous stage, when the abnormal cells exist only in the outer layer of the cervix and haven't invaded deeper tissues. "If untreated, the abnormal cells may convert to cancer cells," says Bobbie Gostout, M.D., principal investigator and a Mayo Clinic gynecological surgeon. "These precancerous abnormal cells are rarely life-threatening and typically require only outpatient treatment. However, about 1 in 5 women that we treat will have recurrent Pap smear abnormalities. We hope that activation of the immune system will help to prevent future abnormal Pap smears."

Participants will be randomized to get either imiquimod then removal of the abnormal cells or removal of the abnormal cells alone, which is currently the standard treatment. Those participants who are randomly assigned to imiquimod will have treatment to remove the abnormal cells one to two months after beginning the study. Participants who are randomly assigned to standard treatment will have a procedure to remove the abnormal cells as soon as they can schedule an appointment. Follow-up tests and examinations will begin at three months and continue up to five years after the start of treatment. Remuneration will be offered.

Those interested in receiving more information, or to participate in the study, should contact Deb at 507-255-3812.

# # #

Contact:
Richard D. Hurt, Jr.
507-266-2166 (days)
507-284-2511 (evenings)
e-mail: newsbureau@mayo.edu

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