The grant is the largest of its kind in the world. Up to this point in the world of cancer research, little has been done to study men's roles in spreading the sexually transmitted organism linked to cervical cancer in women. The men will be followed every six months for four years. They need not have the HPV virus. But they must be willing to visit a clinic at Moffitt twice a year for the four-year study duration.
Giuliano is Moffitt's Program Leader for Risk Assessment, Detection and Intervention and a professor of Interdisciplinary Oncology at the University of South Florida College of Medicine. She is recruiting 3,000 healthy men, ages 18 to 44, at one site in the United States, one in Mexico and one in Brazil. The work could help determine whether a vaccine for males should be employed in the arsenal against cervical cancer. The study is of great interest in Latin America, where rates are higher than in the United States. Hispanic women in the United States have significantly elevated rates compared to other women, according to Giuilano.
Why study men in regard to a cancer that hits women? "We need to know what the rates of new infections are, how long they last, whether they respond to antibodies," she explains. "We are only a year or two away from having a vaccine for women licensed by the U.S. Food and Drug Administration. We don't know if we need to vaccinate men."
Latin American countries suffer "the highest rates of invasive cervical cancer in the world," she says. "And that's where many of our new immigrant populations in Florida are coming from."
Vaccine research is exciting to scientists because preliminary data indicate that it is a means to prevent cancer of the cervix. In developing countries this would be lifesaving, as few women have access to the Pap smear, an effective early screening method that has significantly reduced the rate of cervical cancer in the United States in the past 50 years. "We are getting closer to eradicating cervical cancer" through prevention, Giuilano says.
HPV is the most common sexually transmitted infection in the United States. It affects the skin in the genital area as well as the anal canal. Condoms do not protect against HPV and the infection can lead to genital warts. To date, there is no cure for HPV. HPV is passed from one person to another by contact with infected skin, frequently during sex. HPV infects the penis or the female genitals where is often remains unseen but can be carried to unsuspecting partners during sex.
In men, genital warts appear as growths or bumps on the penis, scrotum, in or around the anus, or groin. Warts may be raised or flat, single or multiple, small or large. Sometimes they are so small that they can't be seen by the naked eye. Some people only have one episode of genital warts, while others have recurrences. In a small percentage of men, infection with certain HPV types will result in precancer or cancer of the penis or the anal canal.
The Mexican study site is Cuernavaca; the Brazilian is São Paulo. Men in Florida who wish to volunteer for the study trial should call (813) 745-6996.
Giuliano's other research interests include cancer epidemiology biomarkers, nutritional supplements and diet in risk reduction, breast cancer and cancer screening. She left the University of Arizona to join Moffitt and USF in July 2004.
In 2001, the National Cancer Institute awarded Moffitt the status of a Comprehensive Cancer Center in recognition of its excellence in research and contributions to clinical trials, prevention and cancer control. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in the U.S. News & World Report as one of the top cancer hospitals in America. Moffitt's sole mission is to contribute to the prevention and cure of cancer.