ITMO public health
Last update : 12/17/2020 | Version : 8 | ID : 3162
| General | |
| Identification | |
| Detailed name | The French E3N Prospective Cohort Study |
| Sign or acronym | E3N Study |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°327346 V 13, CPP (03/12/2008) |
| General Aspects | |
| Medical area |
Biology Cancer research Cardiology Dermatology, venereology Disability/handicap Endocrinology and metabolism Gastroenterology et hepatology Geriatrics Gynecology/ obstetrics Hematology Infectious diseases Neurology Pneumology Psychology and psychiatry Radiology and medical imaging Rheumatology Study of allergies Traumatology |
| Study in connection with Covid-19 |
Yes |
| Health determinants |
Genetic Geography Lifestyle and behavior Medicine Nutrition Occupation Pollution Social and psychosocial factors |
| Scientific investigator(s) (Contact) | |
| Name of the director | Severi |
| Surname | Gianluca |
| Address |
Gustave Roussy Institute, Espace Maurice Tubiana, 114 rue Edouard Vaillant, 94805 Villejuif |
| Phone | +33 (0)1 42 11 41 48 |
| gianluca.severi@inserm.fr | |
| Unit | Inserm - Centre de Recherche en Epidémiologie et Santé des Populations (CESP) - Team Exposome and Heredity |
| Organization | Inserm, Université Paris-Saclay, Institut Gustave Roussy |
| Name of the director | Boutron-Ruault |
| Surname | Marie-Christine |
| Address |
Gustave Roussy Institute, Espace Maurice Tubiana, 114 rue Edouard Vaillant, 94805 Villejuif |
| Phone | +33 (0)1 42 11 64 66 |
| Unit | Inserm - Centre de Recherche en Epidémiologie et Santé des Populations (CESP) - Team Exposome and Heredity |
| Organization | Inserm, Université Paris-Saclay, Institut Gustave Roussy |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | European EPIC study (European Prospective Investigation into Cancer and Nutrition) |
| Funding | |
| Funding status |
Mixed |
| Details | Ligue nationale contre le Cancer, Inserm, Gustave Roussy, MGEN, European Union (for the EPIC study) - Additional funding through call for projects |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale - Inserm |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Université Paris-Saclay |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Institut Gustave Roussy |
| Organisation status |
Both |
| Organisation status | |
| Presence of scientific or steering committees |
Yes |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A population file |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | In 1990, recruiting via an informative MGEN-INSERM letter sent along with an inclusion questionnaire to all women who are members of the MGEN and born between 1925 and 1950.. |
| Database objective | |
| Main objective | Detecting risk factors of cancer and chronic pathologies in women |
| Inclusion criteria | Women born between 1925 and 1950 and affiliated with MGEN (Mutuelle Générale de l'Education nationale) |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
General population |
| Pathology | |
| Gender |
Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 1990 |
| Date of last collection (YYYY or MM/YYYY) | 2020 |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | 98 995 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | Anatomopathological report and / or hospital records to confirm and clarify the reported diseases |
| Declarative data (detail) |
Paper self-questionnaire Internet self-questionnaire Phone interview |
| Details of collected declarative data | Lifestyle and health information |
| Paraclinical data (detail) | imaging (mammographies....) |
| Biological data (detail) | within the framework of case/controls studies: hormone levels, vitamin status, biomarkers |
| Administrative data (detail) | identifying data |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma Fluids (saliva, urine, amniotic fluid, …) Tissues DNA |
| Details of biobank content | Blood from a sample of 25,000 women taken between 1994 and 1998: erythrocytes, buffy coat (lymphocytes), serum, plasma. Saliva from a sample of 47,000 other women collected between 2009 and 2011. Tumor Bank : breast cancers' tumoral tissues |
| 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 | Self-questionnaire at inclusion and then every three years during follow-up: Collection of data on the state of health, lifestyle, plus specific questionnaires under the responsibility of a researcher or for another project (on sub-samples).- Clinical examination at inclusion for a sub-sample of 25,000 women in the cohort: pulse, blood pressure, weight, height. Data collected between 1994 and 1998 when blood samples were taken.- Questionnaire with the general practitioners in the case of a pathology declared by the woman: confirmation and anatomopathological report for more than 80 % of cancers. |
| Classifications used | ICD 9 and ICD 10 |
| Participant monitoring |
Yes |
| Monitoring procedures |
Monitoring by contact with the participant (mail, e-mail, telephone etc.) Monitoring by contact with the referring doctor Monitoring by crossing with a medical-administrative database Monitoring by crossing with a morbidity register |
| Details on monitoring of participants | The duration of follow-up for the women participating in the study is undetermined, as the objective is to follow them as long as possible, until death. |
| Followed pathology | C00-C97 - Malignant neoplasms |
| E10-E14 - Diabetes mellitus | |
| G20 - Parkinson disease | |
| N80 - Endometriosis | |
| J45 - Asthma | |
| I10-I15 - Hypertensive diseases | |
| K50 - Crohn disease [regional enteritis] | |
| K58 - Irritable bowel syndrome | |
| F32 - Depressive episode | |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CépiDC, health insurance care reimbursement data (SNIIR-AM), MGEN |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/E3N |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=E3N-EPIC+OR+%28E3N+AND+%28cohort+OR+escape%29%29+NOT+23110838[uid] |
| Description | List of publications in Pubmed |
| Link to the document | http://epic.iarc.fr/ |
| Link to the document | https://www.e3n.fr/les-articles-scientifiques |
| Description | List of the principal publications of the team |
| Access | |
| Dedicated website | https://www.e3n.fr |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | Data access methods for outside teams: authorization request to the scientific committee of the E3N study |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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