Human Papillomavirus InfectionEPAHTOSNCT07858201
Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression
A study testing Anal Self-Sampling for High-Risk HPV Detection in people with Human Papillomavirus Infection and Anal HPV Infection, run by University Hospital, Montpellier.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Human Papillomavirus Infection, Anal HPV Infection, Human Papillomavirus 16 Infection
- What is being tested?
- Anal Self-Sampling for High-Risk HPV Detection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- History of anal cancer.
- Current pregnancy.
- Legal incapacity or inability to provide informed consent.
- Participation deemed inappropriate by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression (EPAHTOS)
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.
Read more
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.
- Being tested
- Anal Self-Sampling for High-Risk HPV Detection
- Keywords
- Anal HPV Infection, Anal Intraepithelial Neoplasia, Anal Cancer
- Medical subject headings
- Papillomavirus Infections, Anus Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal Self-Sampling for High-Risk HPV DetectionDiagnostic test
Self-collected anal sampling performed for detection of high-risk human papillomavirus (HPV) infection, including HPV-16, using molecular testing.
| Study group | Role | What they receive |
|---|---|---|
| Women Solid Organ Transplant Recipients | Experimental | 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. Receives: Diagnostic Test: Anal Self-Sampling for High-Risk HPV Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anal HPV-16 infection
Prevalence of anal HPV-16 infection determined by high-risk HPV testing performed on self-collected anal samples.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07858201
- Sponsor's protocol ID
- RECHMPL26_0072
- Acronym
- EPAHTOS
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression (EPAHTOS)
- ClinicalTrials.gov ID
- NCT07858201
- Acronym / sponsor ID
- EPAHTOS / RECHMPL26_0072
- Keywords
- Anal HPV Infection, Anal Intraepithelial Neoplasia, Anal Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women Solid Organ Transplant Recipients | Experimental | Diagnostic Test: Anal Self-Sampling for High-Risk HPV DetectionWomen 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- History of anal cancer.
- Current pregnancy.
- Legal incapacity or inability to provide informed consent.
- Participation deemed inappropriate by the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anal Self-Sampling for High-Risk HPV DetectionSelf-collected anal sampling performed for detection of high-risk human papillomavirus (HPV) infection, including HPV-16, using molecular testing. | Diagnostic test | Women Solid Organ Transplant Recipients |
Primary outcome
Prevalence of anal HPV-16 infection
Time frame: At baseline
Prevalence of anal HPV-16 infection determined by high-risk HPV testing performed on self-collected anal samples.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Anal Self-Sampling for High-Risk HPV Detection in people with Human Papillomavirus Infection and Anal HPV Infection, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie FAURE (04 67 33 54 80, s-faure@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of anal HPV-16 infection (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.