Although anal cancer is increasing at a rate of about 2% a year, no routine screening or treatment protocols exist to diagnose the disease in its early precancerous stages. Of course, there are methods that clinicians use to find anal cancer – including digital anorectal exams, anal pap smears, and high resolution anoscopies (HRA) –  but it is not required that doctors do a routine check for the disease or it’s biological precurser, high-grade anal intraepithelial neoplasia (HGAIN), even if you have risk factors.

An important step in the prevention of anal cancer, would be a standardized approach to screen and treat HGAIN which is caused by high-risk HPV. The treatment of HGAIN could potentially prevent progression to anal cancer. It is currently recommended that the biological precurser to cervical cancer, high-grade cervical intraepithelial neoplasia (HGCIN), for example, is treated to prevent it from becoming cervical cancer. Since cervical cancer screening and treatment was implemented in the United States, cervical cancer rates have decreased by 80%. To establish an anal screening or treatment protocol recommended by the federal government, however, we need a study that proves certain treatments are effective.

On September 8, 2011 the HPV and Anal Cancer Foundation led a coalition of organizations in an advocacy effort to the NIH’s Clinical and Translational Research Operations Committee to fund the HOST-HGAIN Outcome Study, the first randomized controlled trial for anal precancer screening and treatment. The study will evaluate the efficacy of screening and treating anal precancer.

Led by Dr. Joel Palefsky of the University of California, San Francisco, the key objectives of the study are to:

1. Determine the effectiveness of screening for and treating HGAIN to reduce the incidence of anal cancer in HIV-positive men and women.

2. To create a bank of blood, anal swab and tissue specimens to support correlative science studies of molecular pathogenesis and biomarkers of progression to anal cancer.

The study will enroll HIV-infected men and women over the age of 35, a group with a high risk of expressing HGAIN, although the results of the study can be applied to HIV-uninfected patients, as well. Any patient that develops cancer will be removed from the study in order to pursue the appropriate care.

If treatment is shown to be effective, we are hopeful that the government and medical community will embrace these procedures as standards of care. Once guidelines are in place, then more clinicians will be trained in these procedures, and more patients will be diagnosed and treated earlier.

In addition to studying the efficacy of treatment, the study will also collect biospecimens, such as HGAIN tissue. These can be used to study the progression from HGAIN to invasive anal cancer.  This specimen collection will also be of great value in understanding the pathogenesis of other HPV-related cancers, including cervical cancer and oral cancer. HGAIN specimins are important because cervical lesions are routinely treated, and there are not yet definable oral precancerous stages.

The HPV and Anal Cancer Foundation was joined by the following twelve organizations in their advocacy letter to NIH: American Social Health Association, the Farrah Fawcett Foundation, Gay Men’s Health Crisis, Global Initiative Against HPV and Cervical Cancer, the HPV Support Network, International Rectal Microbicide Advocates, LGBT Cancer Network , National Cervical Cancer Coalition, the Oral Cancer Foundation, Project Inform, STOP AIDS Project, and Treatment Action Group.

About the CCCT/CTROC

The Clinical and Translational Research Operations Committee (CTROC) is an advisory committee to the CCCT and consists of representatives from various NCI departments. The committee reviews and prioritizes NCI-supported clinical trials, correlative science programs, and translational research.

The Coordinating Center for Clinical Trials (CCCT) is run out of the National Institutes of Health (NIH). Established in 2006, the CCCT guides the implementation of recommendations made by the National Cancer Advisory Board’s (NCAB)’s Clinical Trials Working Group (CTWG) and Translational Research Working Group (TRWG).  In conjunction with all NCI Divisions, Offices, and Centers, CCCT facilitates collaborations that expedite translational and clinical cancer research.