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| Name | Class |
|---|---|
| INSERM SC10-US19 | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-resolution anoscopy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-resolution anoscopy | Procedure | The study includes 2 visits:
|
| Measure | Description | Time Frame |
|---|---|---|
| High-Grade Squamous Intraepithelial Lesion (HSIL) and/or anal cancers diagnosed by an high-resolution anoscopy (HRA) | Within the 10 years prior to HPV sign study participation, or at the study proctological examination in the study. |
| Measure | Description | Time Frame |
|---|---|---|
| HPV molecular signatures obtained using the Capture-HPV technique: HPV mutations, integration into the human genome | at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study. | |
| Nature of abnormalities on High resolution anoscopy (HRA): condylomas, lesions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatoumata Coulibaly | Contact | 0144236110 | +33 | fatoumata.coulibay@inserm.fr |
| Mathilde Ghislain, MSc | Contact | 0145595229 | +33 | mathilde.ghislain@inserm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Caroline Lascoux-Combe, Dr | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| David Veyer, Pharm D,PhD | Hôpital Européen Georges-Pompidou | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital de la Croix Rousse - SMIT | Recruiting | Lyon | 69004 | France |
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Transversal, non-comparative, multicenter study.
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Lesions and condylomas are described as follows: location and type.
| 10 years after participation in the ANRS IPERGAY trial |
| Nature of abnormalities on anal cytology: lesions location, lesions type, lesions grade. | at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study. |
| Nature of abnormalities on anal histology of lesions: location, type, grade | 10 years after participation in the ANRS IPERGAY trial |
| Presence of different HPV virus types in the oropharynx | at the time of the ANRS IPERGAY-HPV sub-study, and 10 years later, in the HPVsign study. |
| Hôpital Saint-Louis - SMIT | Recruiting | Paris | 75010 | France |
|
| Hôpital Tenon - SMIT | Recruiting | Paris | 75020 | France |
|
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D001005 | Anus Neoplasms |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012004 | Rectal Neoplasms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
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