HPV InfectionAPOSYNCT06302725
Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
A study testing Vaginal self sampling detecting HPV in people with HPV Infection and Systemic Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- HPV Infection, Systemic Disease
- What is being tested?
- Vaginal self sampling detecting HPV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 3 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective and retrospective patient
- Women aged 30 to 65 years old
- presenting with MSIA, MSIA includes Systemic lupus erythematosus Sjögren's syndrome Systemic scleroderma Mixed connective tissue disease Inflammatory myositis Systemic sarcoidosis Systemic vasculitis Behçet's disease Adult-onset Still's disease IgG4-related disease Autoimmune cytopenia (autoimmune hemolytic anemia, immune thrombocytopenic purpura, Evans syndrome) Susac syndrome
- Followed in the internal medicine department of Bichat Hospital, Paris
- Not up to date with gynecological follow-up (i.e., Pap smear more than one year old or undatable) (for retrospective patients: at the time of initial screening)
- Retrospective patient
- Patient who underwent Pap smear screening less than one year before the start of the study
Who cannot join
- Prospective and retrospective patient
- Patient under legal protection, guardianship, or trusteeship
- History of colpohysterectomy
- Not affiliated with a social security scheme (general or CMU)
- Absence of informed and written consent
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Interne - Hôpital Bichat Claude Bernard
Paris, 75018
About this study
Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To describe the factors associated with the presence of HPV infection - To determine the rate of HPV clearance after one year, during the second screening at 12 months- To determine the percentage of pre-cancerous cervical lesions and cervical cancer in the event of subsequent cervical smear - To determine the factors associated with persistence (or non-clearance ) of HPV infection - To determine the factors associated with the presence of pre-cancerous and cancerous cervical lesions - To determine the characteristics, tolerance and acceptability of VSS - To determine the rate of cervical cancer screening carried out following French Health Authorities guidelines -To determine the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: presence of HPV infection during follow-up. 3/ Characteristics, acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 6/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressants; variable to be explained: presence of cervical precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 7/ HPV vaccination coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at second screening at one year, in the case of initial positivity (Persistence of HPV infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: persistence of cervical HPV infection at one year (in the case of initial positivity).
- Conditions
- HPV Infection, Systemic Disease
- Being tested
- Vaginal self sampling detecting HPV
- Keywords
- HPV, systemic disease, cervical cancer screening, vaginal self sampling
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal self sampling detecting HPVProcedure or surgery
IMIDs patients who are not up to date with CCS be included into the study to perform a vaginal self-screening (VSS) A positive VSS will be confirmed by a standard HPV test and management of the results of standard HPV test or VSS will be performed as planned following HAS guidelines. For women with a positive VSS, follow-up results (HPV test and cytology, biopsy, etc.) will be collected according to the usual procedures of the screening facility and in accordance with the recommendations of the Health authorities
| Study group | Role | What they receive |
|---|---|---|
| Vaginal self sampling detecting HPV | Experimental | Not described Receives: Procedure: Vaginal self sampling detecting HPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of HPV infection (yes/no) after VSS proposal
Measured: at one year
Secondary outcomes (2)
the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population
Measured: at inclusion and at one year after inclusion
The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population
Measured: at inclusion and at one year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2024
- Primary completion16 Jun 2026
- Study completion3 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tiphaine Goulenok, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302725
- Sponsor's protocol ID
- APHP231514
- Other IDs
- 2023-A02623-42
- Acronym
- APOSY
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goulenok T, Sierra C, Florence AM, Gonthier C, Bucau M, Papo T, Mageau A, Ferre VM, Sacre K; APOSY study group. Prevalence and risk factors for high-risk human papillomavirus infection in patients with immune-mediated inflammatory diseases: a prospective study. RMD Open. 2026 Jul 15;12(3):e006955. doi: 10.1136/rmdopen-2026-006955.
PubMed 42457210Goulenok T, Sacre K. HPV Infection and Prevention in Patients With Immune-Mediated Inflammatory Diseases: A Scoping Review. J Clin Rheumatol. 2024 Oct 1;30(7S Suppl 1):S34-S41. doi: 10.1097/RHU.0000000000002122.
PubMed 39325123
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT06302725
- Acronym / sponsor ID
- APOSY / APHP231514
- Conditions
- HPV Infection, Systemic Disease
- Keywords
- HPV, systemic disease, cervical cancer screening, vaginal self sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 16 Jun 2026 (actual)
- Study completion
- 3 Jul 2026 (actual)
- First posted
- 12 Mar 2024 (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.
Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To describe the factors associated with the presence of HPV infection - To determine the rate of HPV clearance after one year, during the second screening at 12 months- To determine the percentage of pre-cancerous cervical lesions and cervical cancer in the event of subsequent cervical smear - To determine the factors associated with persistence (or non-clearance ) of HPV infection - To determine the factors associated with the presence of pre-cancerous and cancerous cervical lesions - To determine the characteristics, tolerance and acceptability of VSS - To determine the rate of cervical cancer screening carried out following French Health Authorities guidelines -To determine the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: presence of HPV infection during follow-up. 3/ Characteristics, acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 6/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressants; variable to be explained: presence of cervical precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 7/ HPV vaccination coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at second screening at one year, in the case of initial positivity (Persistence of HPV infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: persistence of cervical HPV infection at one year (in the case of initial positivity).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal self sampling detecting HPV | Experimental | Procedure: Vaginal self sampling detecting HPV |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Prospective and retrospective patient
- Women aged 30 to 65 years old
- presenting with MSIA, MSIA includes Systemic lupus erythematosus Sjögren's syndrome Systemic scleroderma Mixed connective tissue disease Inflammatory myositis Systemic sarcoidosis Systemic vasculitis Behçet's disease Adult-onset Still's disease IgG4-related disease Autoimmune cytopenia (autoimmune hemolytic anemia, immune thrombocytopenic purpura, Evans syndrome) Susac syndrome
- Followed in the internal medicine department of Bichat Hospital, Paris
- Not up to date with gynecological follow-up (i.e., Pap smear more than one year old or undatable) (for retrospective patients: at the time of initial screening)
Key exclusion criteria (5 listed)
- Prospective and retrospective patient
- Patient under legal protection, guardianship, or trusteeship
- History of colpohysterectomy
- Not affiliated with a social security scheme (general or CMU)
- Absence of informed and written consent
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 |
|---|---|---|
| Vaginal self sampling detecting HPVIMIDs patients who are not up to date with CCS be included into the study to perform a vaginal self-screening (VSS) A positive VSS will be confirmed by a standard HPV test and management of the results of standard HPV test or VSS will be performed as planned following HAS guidelines. For women with a positive VSS, follow-up results (HPV test and cytology, biopsy, etc.) will be collected according to the usual procedures of the screening facility and in accordance with the recommendations of the Health authorities | Procedure or surgery | Vaginal self sampling detecting HPV |
Primary outcome
prevalence of HPV infection (yes/no) after VSS proposal
Time frame: at one year
2 secondary outcomes
the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population
Time frame: at inclusion and at one year after inclusion
The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population
Time frame: at inclusion and at one year after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 42457210Goulenok T, Sierra C, Florence AM, Gonthier C, Bucau M, Papo T, Mageau A, Ferre VM, Sacre K; APOSY study group. Prevalence and risk factors for high-risk human papillomavirus infection in patients with immune-mediated inflammatory diseases: a prospective study. RMD Open. 2026 Jul 15;12(3):e006955. doi: 10.1136/rmdopen-2026-006955.
- Derived from this study: PubMed 39325123Goulenok T, Sacre K. HPV Infection and Prevention in Patients With Immune-Mediated Inflammatory Diseases: A Scoping Review. J Clin Rheumatol. 2024 Oct 1;30(7S Suppl 1):S34-S41. doi: 10.1097/RHU.0000000000002122.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Tiphaine Goulenok, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal self sampling detecting HPV in people with HPV Infection and Systemic Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of HPV infection (yes/no) after VSS proposal (time frame: at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06302725, which also lists 2 linked publications.
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 7 Jul 2026.