Diaconesses
Paris, France
NCT Number: NCT02287961
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
Looking for future studies?
Notify Me35 year–80 year
Male
Interventional
Not applicable
Paris, France
Intervention (procedure):
Only if lesion suggestive of Anal Intraepithelial Neoplasia (AIN) detected during High Resolution Anoscopy (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):
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(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
at 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 AIN detected during High Resolution Anoscopy
Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)
Time frame: Initial inclusion visit
Time frame: Initial inclusion visit
Time frame: Month 24
Time frame: Month 6
Time frame: Month 12
Time frame: Month 18
Time frame: Month 24
ANRS, Emerging Infectious Diseases
Other Gov
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.
Acronym: APACHES
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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