Infections

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Papillomavirus Infections

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Disease Attributes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

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DNA Virus Infections

Tumor Virus Infections

Anal Cancer

* Standard proctologic examination with digital rectal examination and 2 anal swabs at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits
* High resolution anoscopy 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 only if lesion suggestive of AIN detected during High Resolution Anoscopy
* High Resolution Anoscopy biannually only if high-grade lesion (ASC-H, HSIL ou AIN2/3)

(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

Standard proctologic examination

at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits

High resolution anoscopy

only if lesion suggestive of AIN detected during High Resolution Anoscopy

Biopsy(ies) during High Resolution Anoscopy

Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)

High Resolution Anoscopy biannually

Isabelle Etienney

Gary Clifford

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

* Detection of high-grade cytological and histological anal lesions by high resolution anoscopy
* Spontaneous regression of high-grade anal lesions
* Detection of anal HPV infection

Intervention (procedure):

* Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
* Standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
* High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)

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):

* Patient medical interview (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
* Standard proctologic examination with digital rectal examination and 2 anal swabs (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)
* High resolution anoscopy (initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits)

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

Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men

Natural History of Anal Human Papillomavirus Infection and Associated Disease in HIV-infected Men Who Have Sex With Men: Towards an Evidence Base for the Prevention of Anal Cancer.

ANRS, Emerging Infectious Diseases

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men	NCT02287961	Hiv Infection	Standard procto... High resolution... Biopsy(ies) dur... High Resolution...	35 Years - 80 Years	ANRS, Emerging Infectious Diseases
Human Papillomavirus Infection and Related Anal Lesions in HIV-positive Men Who Have Sex With Men	NCT02287961	Hiv Infection	Standard procto... High resolution... Biopsy(ies) dur... High Resolution...	35 Years - 80 Years	ANRS, Emerging Infectious Diseases

Spots Global Cancer Trial Database for biopsy(ies) during high resolution anoscopy