CTN 330: Predicting and evaluating anal cancer in HIV with novel biomarkers (The PEACH Study)

About The Study

The PEACH Study aims to improve the accuracy of anal cancer screening in men who have sex with men (MSM) living with HIV, a population that is disproportionately affected by this type of cancer. The study will test different combinations of screening tests to determine the most efficient way of identifying people who should be prioritized for immediate further treatment.

About The Disease

Human papillomavirus (HPV) is the most common sexually transmitted infection in the world. As is the case for cervical cancer, HPV is the cause of several types of anal cancer. Although there are more than 170 types of HPV, only a handful can cause cancer, with one type (HPV-16) responsible for over 75% of anal cancers. The rate of HPV-associated anal cancer in MSM is significantly higher than the general population and even higher in MSM living with HIV. People living with HIV are vulnerable to more persistent HPV infection as well as more accelerated development of associated cancers.

Current methods for detecting anal cancer are inadequate. Anal Pap smears do not accurately identify people who have cancer or precancerous lesions due to a high rate of false negatives. Because anal cancers are mostly caused by long-term HPV infection, one-time HPV testing is also not effective at identifying those at highest risk for developing cancer. Therefore, the PEACH Study team is including new biomarkers associated with HPV and HPV-associated cancers. The team will test different combinations of existing tests and the new biomarkers, used over several years, to determine which method is the most effective screening method. The PEACH Study builds on CTN 292A, which examined several of these tests used at a single clinical visit

Study Approach

CTN 330 aims to enroll 1,000 MSM living with HIV in Vancouver and Toronto. The study will take place over three years. The initial study visit will involve a questionnaire, an anal Pap test, biomarker collection (all collected through anal swabs), and high-resolution anoscopy to screen for anal cancer. Participants will then attend annual study visits over the next three years which will involve many of the same tests. During anoscopy, suspicious tissues may be biopsied; participants whose biopsies indicate pre-cancers will be offered the usual treatment. Any cancers diagnosed will be immediately referred to a specialist for further management. The study team will compare and contrast the effectiveness of the different strategies, and will ultimately develop a position statement on HPV screening, treatment, and vaccination in MSM living with HIV.