Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression (EPAHTOS)
| Registry | NCT07858201, acronym EPAHTOS |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, basic science |
| Enrollment | 190 (Estimated) |
| Sponsor | University Hospital, Montpellier (Other) |
| Conditions | Human Papillomavirus Infection, Anal HPV Infection, Human Papillomavirus 16 Infection |
| Interventions | Anal Self-Sampling for High-Risk HPV Detection (Diagnostic test) |
| Dates | start 2026-10-01 (estimated), primary completion 2028-10-01 (estimated), completion 2028-10-01 (estimated), first posted 2026-10-05, last updated 2026-10-05 |
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All trials for Human Papillomavirus Infection All trials for Anal HPV Infection All trials of Anal Self-Sampling for High-Risk HPV Detection
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Women Solid Organ Transplant Recipients | Experimental | Diagnostic Test: Anal Self-Sampling for High-Risk HPV Detection | 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. Participants complete a questionnaire and perform a self-collected anal sample for high-risk HPV testing. |
Sex: Female, ages: 18 Years to 75 Years
Inclusion Criteria: * Female aged 18 to 75 years. * Recipient of a kidney, liver and/or heart transplant for more than 10 years, or cumulative exposure to immunosuppressive therapy for more than 10 years. * Affiliated to a health insurance system. * Able to understand study procedures and provide written informed consent. Exclusion Criteria: * History of anal cancer. * Current pregnancy. * Legal incapacity or inability to provide informed consent. * Participation deemed inappropriate by the investigator.