- Cohort of High-Grade AIN3 Anal Dysplasia
Head :
Gault Nathalie, Département Epidémiologie et Recherche clinique
Last update : 09/09/2020 | Version : 1 | ID : 8099
| General | |
| Identification | |
| Detailed name | Cohort of High-Grade AIN3 Anal Dysplasia |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Avis CCTIRS n°12239 (11 avril 2012), accord CNIL n° 912217 (10/10/2012), avis du Comité d'éthique indépendant GHU Nord n° 12-032 (19/04/2012). |
| General Aspects | |
| Medical area |
Cancer research Gastroenterology et hepatology Infectious diseases |
| Health determinants |
Lifestyle and behavior |
| Keywords | High-grade anal dysplasia (AIN3), epidermoid carcinoma of the anus, risk factors |
| Scientific investigator(s) (Contact) | |
| Name of the director | Gault |
| Surname | Nathalie |
| Address | Hôpital Bichat, Département Epidémiologie et Recherche clinique, 46 rue Henri Huchard, 75877 Paris Cedex 18 |
| Phone | +33 (0)1 40 25 79 32 |
| nathalie.gault@aphp.fr | |
| Unit | Département Epidémiologie et Recherche clinique |
| Organization | APHP.Nord Université de Paris, Hôpital Bichat Claude Bernard |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | COMAD, SNFCP, SIDACTION, La Ligue, MSD |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | APHP |
| Organisation status |
Public |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Name of the contact | Abramowitz |
| Surname | Laurent |
| Address | Hôpital Bichat, Service d'Hépato-gastro-entérologie, 46 rue Henri Huchard, 75877 Paris Cedex 18 |
| laurent.abramowitz@aphp.fr | |
| Unit | Service d'Hépato-gastro-entérologie |
| Organization | APHP.Nord Université de Paris, Hôpital Bichat Claude Bernard |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
Centres participating in the study, hospitals or private practices, are the vast majority of French centres involved in the diagnosis and treatment of anal diseases, particularly squamous cell carcinoma of the anus. Anatomopathological data from these centres will allow the most comprehensive retrospective identification of anal AIN3 lesion cases and their oncological complications since 2000.
Study set up in 2013. Inclusions are interrupted in June 2020 (achievement of the schedulded number of patients). Follow-up still ongoing. |
| Database objective | |
| Main objective | The main objective of the study is the evaluation of 3-year anal carcinoma incidence in patients with anal AIN3 lesions. Secondary objectives are: - To identify patients with an anal AIN3 lesion, risk factors (demographical data, HIV status...), treatment factors (type of therapeutic treatment), virological and immunological factors (HPV genotype, presence or non-presence of P16 and Ki67 proteins) associated with the onset of epidermoid carcinoma of the anus.- To identify if the presence of P16/Ki67 factors and high risk HPV virus is associated with an increased risk of recurrent AIN3 lesions and if this is the case for high-grade dysplasia of the cervix. - To estimate the proportion of adherent patients, and to identify factors associated with compliance monitoring (demographics, HIV status, type of treatment undertaken ...) - to assess the overall feeling of patients towards anal AIN3 lesion therapeutic care. |
| Inclusion criteria | Anal AIN3 lesion diagnosed by histology: - aposteriori for patients with a history of anal AIN3 complicated or not complicated by anal cancer. These cases will be identified from data bases of anatomopathology laboratories in hospitals since 1st January 2000. - patients consulting a proctologist at time of diagnosis for first displasic anal AIN3 lesion. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | D01 - Carcinoma in situ of other and unspecified digestive organs |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 35 specialist patient treatment centres throughout metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2000 |
| Date of last collection (YYYY or MM/YYYY) | 09/2019 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 865 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Paraclinical data (detail) | Standard or high resolution anoscopy (according to usual practices) |
| Biological data (detail) | Biological components: - anal smear - biopsy of lesions - cytology - histological analysis - Ki67 and P16 protein research - research and genotyping of HPV virus |
| Presence of a biobank |
Yes |
| Contents of biobank |
Others |
| Details of biobank content | Other: anal smear. Samples taken during treatment are stored in the CERBA laboratory. |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Data collected retrospectively and prospectively by the proctologist in charge of the medical examination and follow-up consultation. |
| Quality procedure(s) used | monthly data management, queries on missing data or inconsistencies, median follow-up |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the referring doctor |
| Details on monitoring of participants | Follow-up duration is a minimum of 3 years |
| Followed pathology | C00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue |
| D01 - Carcinoma in situ of other and unspecified digestive organs | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
