Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522256
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations with the Presence of High-grade Lesions Andor Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Identification of Molecular Signatures of High-risk Oncogenic HPV and Study of Their Associations with the Presence of High-grade Lesions Andor Anal Cancer 10 Years After Inclusion in the ANRS IPERGAY Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPVsign
Brief 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 andor anal cancers using high-resolution anoscopy HRA during the HPVsign study andor 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 andor anal cancers using high-resolution anoscopy HRA during the HPVsign study andor diagnosed since the end of participation in the ANRS IPERGAY trial
Also the study proposes to
study the association between the presence of HSIL andor 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 andor anal cancer
compare the presence of different HPV virus types in the oropharynx concomitant with HRA and during participation in the ANRS IPERGAY trial
The study proposes to evaluate the cumulative incidence of high-grade lesions andor anal cancers using high-resolution anoscopy HRA during the HPVsign study andor diagnosed since the end of participation in the ANRS IPERGAY trial
Also the study proposes to
study the association between the presence of HSIL andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None