Clinical Research Directory

Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression

Anal canal cancer is primarily associated with persistent infection by high-risk human papillomavirus (HR-HPV), particularly HPV-16. Women who have undergone solid organ transplantation are at increased risk of anal cancer because of the chronic immunosuppression required to maintain graft function. However, epidemiological data regarding the prevalence of anal HPV-16 and other HR-HPV types in this population remain limited and sometimes conflicting. EPAHTOS is a single-center, cross-sectional, observational study (French Category 2 Interventional Research Involving Human Participants \[RIPH 2\]) conducted at Montpellier University Hospital. The study aims to evaluate the prevalence of anal HPV-16 carriage among women aged 18 to 75 years who underwent kidney, liver, and/or heart transplantation more than 10 years previously, or who have received cumulative immunosuppressive therapy for more than 10 years. A total of 190 participants will be enrolled. At the inclusion visit, participants will receive information about the study, provide written informed consent, complete a self-administered questionnaire including questions on HPV infection risk factors, and perform a self-collected anal sample for the detection of high-risk HPV by polymerase chain reaction (PCR). This test allows identification of HPV-16 as well as other HR-HPV genotypes. The primary objective is to estimate the prevalence of anal HPV-16 carriage. Secondary objectives include assessing the distribution of other anal HR-HPV genotypes, describing cytological abnormalities associated with HR-HPV infections, estimating the prevalence of anal histological lesions detected by high-resolution anoscopy among eligible participants, identifying factors associated with HR-HPV carriage, evaluating the feasibility of anal self-sampling, and describing the distribution of cervical HR-HPV infections. In accordance with French recommendations, participants testing positive for HPV-16 will receive standard clinical management including reflex anal cytology and, in the event of a cytological abnormality, referral for proctology consultation with high-resolution anoscopy. Within the framework of the study, participants carrying an HR-HPV genotype other than HPV-16 and presenting abnormal cytology will also be offered standard proctological evaluation to ensure that clinically significant anal lesions are not overlooked. The results of this study will provide updated information on the epidemiology of HPV infections among female solid organ transplant recipients and may contribute to the development of future anal cancer screening strategies in this high-risk population.

Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men

The incidence of anal cancer is increasing, particularly among high-risk groups such as men who have sex with men (MSM), especially those living with HIV. The lack of comprehensive screening programs results in delayed diagnosis and higher mortality. This project aims to establish a screening program for anal cancer in high-risk populations, with a specific focus on those most at risk. Using a prospective study design, the project will assess the effectiveness of early detection and prevention strategies to potentially reduce cancer incidence and improve survival rates. If an HPV-based screening method proves effective, it would serve as a potential implemention for high-risk groups in Denmark, further enhancing early detection and prevention efforts. This study represents the first large-scale, prospective screening initiative for anal cancer in Denmark,specifically targeting MSM. It introduces a novel approach to cancer prevention in this population by building on research in other cancers and adapting it to anal cancer and its specific risk factors. The project is a collaboration between clinical practitioners and academic researchers, ensuring that practical clinical insights guide the research and that research findings are rapidly translated into clinical practice. This partnership will enhance both the quality of the research and its direct application in healthcare. The project is expected to lead to earlier diagnosis of anal cancer, reduced morbidity and mortality among high-risk populations, and the establishment of a screening model that can be applied nationwide. This could significantly reduce the overall healthcare burden associated with late-stage anal cancer and improve patient outcomes across Denmark.

Artesunate Ointment for the Treatment of Anal HSIL in HIV-negative Participants

This is a phase II double blind, placebo-controlled, randomized study of artesunate ointment for the treatment of HIV-negative men and women who have anal high grade squamous intraepithelial lesions (anal HSIL)