The Icahn School of Medicine at Mount Sinai has been awarded a grant of more than $4 million by the National Cancer Institute for a large-scale study to evaluate anal cancer screening in high-risk women who have been previously diagnosed with human papillomavirus (HPV) infection. This multi-center study is a collaboration between the Mount Sinai Anal Dysplasia Screening Program, The University of Texas MD Anderson Cancer Center, and The University of Texas Health Science Center at Houston (UTHealth).
Anal cancer is one of the fastest-rising cancers—in incidence and death rates—in the United States, with the most significant increases occurring among women ages 50 and older, according to the Journal of the National Cancer Institute. Among these women, annual rates of new cases of anal cancer have grown 5% each year during the last two decades, and the number of new anal cancer diagnoses is expected to overtake those of cervical cancer in older women during the next decade.
The five-year trial will evaluate the effectiveness of anal cancer screening interventions for women who are not infected with HIV and who have a history of HPV-related precancers in the lower genital sites including the cervix, vagina, and vulva. Evidence of HPV infection at one genital site has been previously associated with HPV infection in the anus, as well as risk of precancers in the anus. Approximately 90 percent of anal cancers are associated with HPV infection.
By focusing on women who do not have HIV, the new study will target the population with the largest group of anal cancers in the United States, and one that has historically been understudied.
The team of doctors and researchers will screen 300 women to determine how effectively existing tests perform and to estimate the prevalence and incidence of high-risk anal precancers in this group. The research team will also utilize machine learning and mathematical modeling approaches to determine how the study findings would impact at-risk women at the population level, with estimates of the benefits, harms, impact on quality of life, and cost-effectiveness of early testing. Screenings will be conducted at two sites, the Mount Sinai Health System in New York and the MD Anderson Oncology Program at Harris Health Lyndon B. Johnson Hospital in Houston.
“Given there are currently no evidence-based guidelines for screening this high-risk group, our study will lay the groundwork for more effective evaluations of women who have been diagnosed with other conditions that may increase the risk for anal cancer,” says co-principal investigator Keith Sigel, MD, PhD, MPH, associate professor of Medicine (General Medicine and Infectious Diseases) at Icahn Mount Sinai. “We think that early detection and aggressive treatment of precancers may stop the progression to cancer, but there has been very little research on this disease process in this high-risk group of women. With the trend in rising cases among older women, effective prevention methods are urgently needed.”
Sigel will lead the study with Elizabeth Yu Chiao, MD, MPH, Professor of Epidemiology and General Oncology at MD Anderson, and Ashish A. Deshmukh, PhD, MPH, Assistant Professor of Management, Policy & Community Health at UTHealth School of Public Health in Houston.
“This important study builds upon our prior NCI-funded work, which focused on determining optimal anal cancer screening strategies in women and men living with HIV,” Chiao says. “It will provide the necessary data to develop evidence-based anal cancer prevention strategies for high-risk HIV-negative women.”
Deshmukh says women with a history of HPV-associated cancers represent a growing number of vulnerable and understudied individuals at elevated anal cancer risk. “This study is the first of its kind to perform a comprehensive screening evaluation to improve survivorship and quality of life of these women and inform national cancer prevention policy,” he says.