ITMO public health
Last update : 12/17/2020 | Version : 6 | ID : 3101
| General | |
| Identification | |
| Detailed name | Epidemiological Study Concerning The Children of E3N Women |
| Sign or acronym | E4N |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Inserm ethical evaluation comitee (IRB00003888) - For the 4N-G1 cohort : CNIL autorization DR-2014-224. For the E4N-G2 cohort : CNIL autorization DR-2017-049 |
| General Aspects | |
| Medical area |
Biology Cancer research Cardiology Dermatology, venereology Disability/handicap Endocrinology and metabolism Gastroenterology et hepatology Geriatrics Gynecology/ obstetrics Hematology Neurology Pediatrics Pneumology Psychology and psychiatry Radiology and medical imaging Rheumatology Study of allergies Traumatology Urology, andrology and nephrology |
| Study in connection with Covid-19 |
Yes |
| Health determinants |
Genetic Geography Iatrogenic Lifestyle and behavior Nutrition Occupation Pollution Social and psychosocial factors |
| Keywords | family environment, Lifestyle and behaviour, family members, family determinants |
| 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 - CESP, Team "Health across Generations" |
| Organization | Inserm |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | ANR - National Research Agency : Investissments for the future (2011-2019 et 2020-2025) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Paris Saclay University |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Inserm - Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Gustave Roussy Institute |
| Organisation status |
Both |
| 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. |
Family cohort : include the members of the E3N women's family on 3 generations :
- E3N women and their children's fathers (E4N-G1) - E3N women's children (E4N-G2) - E3N women's grandchildren (E4N-G3) |
| Database objective | |
| Main objective |
The familial E3N-E4N study purpose is to study health in relation to the modern way of life in people of the same family over three generations.
The E4N study aims to extend the E3N study by following the descendants of women who participated in the E3N study. The objective is to better understand the onset of major diseases, from genetics, family environment and the environment outside the family. As well as gathering a large amount of prospective epidemiological data, E4N cohort permit the collection of important information concerning phenotypes and genetics. |
| Inclusion criteria |
Women included in the E3N cohort (G1),
Fathers of E3N women's children (G1) Sons and daughters of E3N women (G2), Grandchildren of E3N women (G3). |
| 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 |
General population |
| Pathology | |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | December 2014 (E4N-G1) |
| Date of last collection (YYYY or MM/YYYY) | December 2020 (E4N-G2) |
| Size of the database | |
| Size of the database (number of individuals) |
Greater than 20 000 individuals |
| Details of the number of individuals | 18 000 fathers (E4N-G1) / 50 000 expected children (E4N-G2) / 20 000 expected grandchildren (E4N-G3) |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Anatomical Pathology Reporting for Declared Cancer |
| Declarative data (detail) |
Paper self-questionnaire Internet self-questionnaire Phone interview |
| Details of collected declarative data | Lifestyle and state of health |
| Biological data (detail) | Saliva samples (DNA extraction) |
| Administrative data (detail) | Identification data |
| Presence of a biobank |
Yes |
| Contents of biobank |
Fluids (saliva, urine, amniotic fluid, …) DNA |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Data collection method | For G1: paper self-questionnaires ; For G2 and G3: webquestionnaires, sms, trackers of physical activity; For all: contacts with doctors + matching with the medico-administrative databases of Health Insurance and CNAV |
| Classifications used | CIM 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 | Data collection will take several years and the duration of the study is not limited in time. |
| Followed pathology | II - Neoplasms |
| IV - Endocrine, nutritional and metabolic diseases | |
| V - Mental and behavioural disorders | |
| XI - Diseases of the digestive system | |
| I10-I15 - Hypertensive diseases | |
| E11 - Type 2 diabetes mellitus | |
| G20 - Parkinson disease | |
| I20-I25 - Ischaemic heart diseases | |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CepiDc, SNIIR-AM, CNAV |
| Promotion and access | |
| Promotion | |
| Access | |
| Dedicated website | website of the E4N study |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | External team access: submission of access request to the Scientific Committee of the E4N Study |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
No access |
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