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Multicentric epidemiological non-comparative study in France characterising evolution of anal Human papillomavirus (HPV) infection and related lesions and evaluating markers associated with the observed evolution.
Estimated enrolment: 500
Principal Outcomes
Intervention (procedure):
Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA):
- anal biopsy(ies) during HRA
Only if high-grade lesion:
- HRA biannually
Intervention (procedure):
Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (HRA):
- anal biopsy(ies) during HRA
Only if high-grade lesion (Atypical squamous cells-cannot exclude high-grade squamous intraepithelial lesion (ASC-H), High grade Superficial Intra-epithelial Lesion (HSIL) or AIN2/3):
- HRA biannually
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects | Other |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard proctologic examination | Procedure | (with digital rectal examination and 2 anal swabs) at initial inclusion visit, M12 and M24 follow-up visits and if applicable M6 and M18 control visits |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of high-grade anal lesions by high resolution anoscopy | Initial inclusion visit | |
| Evaluation of anal HPV infection by DNA, RNA and protein detection | Initial inclusion visit | |
| Quantification of spontaneous regression of high-grade anal lesions | Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of anal HPV infection by DNA, RNA and protein detection | Month 6 | |
| Evaluation of anal HPV infection by DNA, RNA and protein detection | Month 12 | |
| Evaluation of anal HPV infection by DNA, RNA and protein detection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle Etienney | Hôpital Diaconesses Paris | Principal Investigator |
| Gary Clifford | International Agency for Research on Cancer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diaconesses | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39052708 | Background | Combes JD, Didelot JM, Radenne S, Zaegel-Faucher O, Lesage AC, Siproudhis L, Piroth L, Marchand L, Heard I, Hoyeau N, Henno S, Darragh TM, Alberts CJ, Clifford GM, Etienney I; ANRS-EP57-APACHES Study group. Cumulative Detection of Anal High-Grade Squamous Intraepithelial Lesions Over 2-Year Follow-up in Men Who Have Sex With Men Living With Human Immunodeficiency Virus in France. J Infect Dis. 2024 Jul 25;230(1):55-60. doi: 10.1093/infdis/jiad506. | |
| 31754686 |
| Label | URL |
|---|---|
| Agence nationale de recherches sur le sida et les hépatites virales (ANRS) | View source |
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| High resolution anoscopy | Procedure | at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits |
|
| Biopsy(ies) during High Resolution Anoscopy | Procedure | only if lesion suggestive of AIN detected during High Resolution Anoscopy |
|
| High Resolution Anoscopy biannually | Procedure | Only if high-grade lesion (ASC-H, HSIL ou AIN2/3) |
|
| Month 18 |
| Evaluation of anal HPV infection by DNA, RNA and protein detection | Month 24 |
| Result |
| Alberts CJ, Heard I, Canestri A, Marchand L, Flejou JF, Piroth L, Ferry T, Didelot JM, Siproudhis L, Henno S, Poizot-Martin I, Darragh TM, Clifford GM, Combes JD, Etienney I; ANRS EP57 APACHES Study group. Incidence and Clearance of Anal Human Papillomavirus (HPV)-16 and HPV-18 Infection, and Their Determinants, Among Human Immunodeficiency Virus-Infected Men Who Have Sex With Men in France. J Infect Dis. 2020 Apr 7;221(9):1488-1493. doi: 10.1093/infdis/jiz623. |
| 30005009 | Result | Clifford GM, Siproudhis L, Piroth L, Poizot-Martin I, Radenne S, Reynes J, Lesage A, Heard I, Henno S, Flejou JF, Marchand L, Combes JD, Etienney I; ANRS EP57 APACHES Study group. Determinants of high-grade anal intraepithelial lesions in HIV-positive MSM. AIDS. 2018 Oct 23;32(16):2363-2371. doi: 10.1097/QAD.0000000000001947. |
| 29394362 | Result | Combes JD, Heard I, Poizot-Martin I, Canestri A, Lion A, Piroth L, Didelot JM, Ferry T, Patey O, Marchand L, Flejou JF, Clifford GM, Etienney I; ANRS EP57 APACHES Study group. Prevalence and Risk Factors for Anal Human Papillomavirus Infection in Human Immunodeficiency Virus-Positive Men Who Have Sex with Men. J Infect Dis. 2018 Apr 23;217(10):1535-1543. doi: 10.1093/infdis/jiy059. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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