Health TrialsbyHealthPanel

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

ConditionsHPV InfectionAnal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • High-resolution anoscopy

    Procedure/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

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: High-resolution anoscopyOther 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ANRS, Emerging Infectious Diseases

Lead sponsor

INSERM SC10-US19

Collaborator

Source ClinicalTrials.gov
Apply now