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RecruitingNCT06522256HPVsignUpdated Dec 4, 2025

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

An interventional study of High-resolution anoscopy in HPV Infection and Anal Cancer, sponsored by ANRS, Emerging Infectious Diseases. Recruiting at 3 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-04.

Sponsored by ANRS, Emerging Infectious Diseases · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.
02

Conditions studied

  • HPV Infection
  • Anal Cancer

Keywords

  • HSIL
03

In context

Papillomavirus Infections

576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.

This study's planned enrollment of 100 is below the median of 235 across 402 interventional studies indexed under Papillomavirus Infections.

Browse Papillomavirus Infections studies →

Lead sponsor

ANRS, Emerging Infectious Diseases is the lead sponsor of 215 studies on the registry; 38 are open to participants now.

Browse ANRS, Emerging Infectious Diseases studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Other
    High-resolution anoscopy

    Procedure: High-resolution anoscopy

Interventions

  • ProcedureHigh-resolution anoscopy

    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

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions.

    Lesions and condylomas are described as follows: location and type.

    Time frame: 10 years after participation in the ANRS IPERGAY trial

  3. 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.

  4. Nature of abnormalities on anal histology of lesions: location, type, grade

    Time frame: 10 years after participation in the ANRS IPERGAY trial

  5. 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.

07

Study locations

3 of 3 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2025 (actual). Primary completion is estimated for Jul 2027, 28 months after the start.

Of 106 non-industry interventional studies with no phase under Papillomavirus Infections, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 28 months is close to that.

Counting every sponsor, half of 115 studies reached it within 26 months; a quarter within 12 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 16, 2024
First posted
Jul 26, 2024
StartActual
Mar 20, 2025
Primary completionEst.
Jul 30, 2027
CompletionEst.
Jul 30, 2027
Last update
Dec 4, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06522256
Lead sponsor
ANRS, Emerging Infectious Diseases
Collaborators
INSERM SC10-US19
Responsible party
Sponsor
First posted
Jul 26, 2024
Start date
Mar 20, 2025
Primary completion
Jul 30, 2027 (estimated)
Completion
Jul 30, 2027 (estimated)
Last update
Dec 4, 2025

Study contacts

Fatoumata Coulibaly
Contact
fatoumata.coulibay@inserm.fr
0144236110 ext. +33
Mathilde Ghislain, MSc
Contact
mathilde.ghislain@inserm.fr
0145595229 ext. +33
Caroline Lascoux-Combe, Dr
principal investigator · Assistance Publique - Hôpitaux de Paris
David Veyer, Pharm D,PhD
study director · Hôpital Européen Georges-Pompidou

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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