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Trial 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
NCT ID:
NCT06522256
Condition:
HPV Infection
Anal Cancer
Conditions: Official terms:
Papillomavirus Infections
Anus Neoplasms
Conditions: Keywords:
HSIL
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Transversal, non-comparative, multicenter study.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
High-resolution anoscopy
Description:
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
Arm group label:
High-resolution anoscopy
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.
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.
Criteria for eligibility:
Criteria:
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:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hôpital de la Croix Rousse - SMIT
Address:
City:
Lyon
Zip:
69004
Country:
France
Contact:
Last name:
Stanislas Ogoudjobi
Email:
stanislas.ogoudjobi@chu-lyon.fr
Contact backup:
Last name:
Dulce Alfaiate, Dr
Facility:
Name:
Hôpital Saint-Louis - SMIT
Address:
City:
Paris
Zip:
75010
Country:
France
Contact:
Last name:
Bénédicte Loze
Email:
benedicte.loze@aphp.fr
Contact backup:
Last name:
Caroline Lascoux-Combe, Dr
Facility:
Name:
Hôpital Tenon - SMIT
Address:
City:
Paris
Zip:
75020
Country:
France
Contact:
Last name:
Thibaut Pélagie
Email:
pelagie.thibaut@aphp.fr
Contact backup:
Last name:
Gilles Pialoux, Pr
Start date:
November 1, 2024
Completion date:
July 30, 2027
Lead sponsor:
Agency:
ANRS, Emerging Infectious Diseases
Agency class:
Other
Collaborator:
Agency:
INSERM SC10-US19
Agency class:
Other
Source:
ANRS, Emerging Infectious Diseases
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06522256
