HPV InfectionHPVsignNCT06522256
Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial
A study testing High-resolution anoscopy in people with HPV Infection and Anal Cancer, run by ANRS, Emerging Infectious Diseases at 3 sites in France.
Trial summary
HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Anal Cancer
- What is being tested?
- High-resolution anoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Mar 2025to 30 Jul 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant in the ANRS IPERGAY clinical trial who was included in the initial HPV sub-study;
- Informed and written signed consent
- Participant with regular health insurance
Who cannot join
- Participant under guardianship or curatorship
- Participant with free State medical assistance
- Participant who disagrees with the use of data collected as part of their participation in the ANRS IPERGAY trial.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital de la Croix Rousse - SMIT
Lyon, 69004
Stanislas Ogoudjobi, stanislas.ogoudjobi@chu-lyon.fr
Dulce Alfaiate, Dr
- Recruiting
Hôpital Saint-Louis - SMIT
Paris, 75010
Bénédicte Loze, benedicte.loze@aphp.fr
Caroline Lascoux-Combe, Dr
- Recruiting
Hôpital Tenon - SMIT
Paris, 75020
Thibaut Pélagie, pelagie.thibaut@aphp.fr
Gilles Pialoux, Pr
About this study
HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.
Read the detailed description
The study aims to enrol 80 to 100 participants in French clinical centres. All the participants have participated to the IPERGAY HPV substudy.
The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.
Also, the study proposes to:
- study the association between the presence of HSIL and/or anal cancer and HPV molecular signatures during participation in the ANRS IPERGAY trial and 10 years after.
- study the evolution of HPV molecular signatures from participation in the ANRS IPERGAY to current study
- compare HRA results with anal cytology results
- compare the results of anal cytology concomitant with HRA with those obtained during participation in the ANRS IPERGAY trial.
- study factors associated with the presence of HSIL and/or anal cancer.
- compare the presence of different HPV virus types in the oropharynx concomitant with HRA and during participation in the ANRS IPERGAY trial.
- Conditions
- HPV Infection, Anal Cancer
- Being tested
- High-resolution anoscopy
- Keywords
- HSIL
- 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.
High-resolution anoscopyProcedure or surgery
The study includes 2 visits:
- a medical consultation for inclusion
- a proctology consultation including the performance of an AHR associated or not with biopsy sampling
| Study group | Role | What they receive |
|---|---|---|
| High-resolution anoscopy | Other | Not described Receives: Procedure: High-resolution anoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA)
Measured: Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.
Secondary outcomes (5)
HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome
Measured: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions.
Lesions and condylomas are described as follows: location and type.
Measured: 10 years after participation in the ANRS IPERGAY trial
Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade.
Measured: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
Nature of abnormalities on anal histology of lesions: location, type, grade
Measured: 10 years after participation in the ANRS IPERGAY trial
Presence of different HPV virus types in the oropharynx
Measured: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start20 Mar 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Transversal, non-comparative, multicenter study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- INSERM SC10-US19
- Responsible party
- Sponsor
- Investigators
- Caroline Lascoux-Combe, Dr, Principal investigator, Assistance Publique - Hôpitaux de ParisDavid Veyer, Pharm D,PhD, Study director, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522256
- Sponsor's protocol ID
- ANRS0251s-HPVSign
- Acronym
- HPVsign
- Status last verified
- Feb 2025
- First submitted
- 16 Jul 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations With the Presence of High-grade Lesions and/or Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial
- ClinicalTrials.gov ID
- NCT06522256
- Acronym / sponsor ID
- HPVsign / ANRS0251s-HPVSign
- Conditions
- HPV Infection, Anal Cancer
- Keywords
- HSIL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- INSERM SC10-US19
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 26 Jul 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.
HPVsign is a cross-sectional, non-comparative, multicenter study involving all participants included in the HPV substudy of the ANRS IPERGAY trial. The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.
Detailed description
The study aims to enrol 80 to 100 participants in French clinical centres. All the participants have participated to the IPERGAY HPV substudy.
The study proposes to evaluate the cumulative incidence of high-grade lesions and/or anal cancers using high-resolution anoscopy (HRA) during the HPVsign study and/or diagnosed since the end of participation in the ANRS IPERGAY trial.
Also, the study proposes to:
- study the association between the presence of HSIL and/or anal cancer and HPV molecular signatures during participation in the ANRS IPERGAY trial and 10 years after.
- study the evolution of HPV molecular signatures from participation in the ANRS IPERGAY to current study
- compare HRA results with anal cytology results
- compare the results of anal cytology concomitant with HRA with those obtained during participation in the ANRS IPERGAY trial.
- study factors associated with the presence of HSIL and/or anal cancer.
- compare the presence of different HPV virus types in the oropharynx concomitant with HRA and during participation in the ANRS IPERGAY trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Transversal, non-comparative, multicenter study.
| Arm | Type | Receives |
|---|---|---|
| High-resolution anoscopy | Other | Procedure: High-resolution anoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant in the ANRS IPERGAY clinical trial who was included in the initial HPV sub-study;
- Informed and written signed consent
- Participant with regular health insurance
Key exclusion criteria (3 listed)
- Participant under guardianship or curatorship
- Participant with free State medical assistance
- Participant who disagrees with the use of data collected as part of their participation in the ANRS IPERGAY trial.
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 |
|---|---|---|
| High-resolution anoscopyThe study includes 2 visits: * a medical consultation for inclusion * a proctology consultation including the performance of an AHR associated or not with biopsy sampling | Procedure or surgery | High-resolution anoscopy |
Primary outcome
High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA)
Time frame: Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.
5 secondary outcomes
HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome
Time frame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions.
Time frame: 10 years after participation in the ANRS IPERGAY trial
Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade.
Time frame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
Nature of abnormalities on anal histology of lesions: location, type, grade
Time frame: 10 years after participation in the ANRS IPERGAY trial
Presence of different HPV virus types in the oropharynx
Time frame: at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study.
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 4 Dec 2025.
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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.
Caroline Lascoux-Combe, Dr principal investigator
Assistance Publique - Hôpitaux de Paris
David Veyer, Pharm D,PhD study director
Hôpital Européen Georges-Pompidou
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-resolution anoscopy in people with HPV Infection and Anal Cancer, run by ANRS, Emerging Infectious Diseases at 3 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Fatoumata Coulibaly (0144236110 ext. +33, fatoumata.coulibay@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA) (time frame: Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study.). 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 4 Dec 2025.