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Active, Not Recruiting

NCT Number: NCT03285230

The French E3N Prospective Cohort Study

The French E3N cohort was initiated in 1990 to investigate the risk factors associated with cancer and other major non-communicable diseases in women.

The participants were insured through a national health system that primarily covered teachers, and were enrolled from 1990 after returning baseline self-administered questionnaires and providing informed consent. The cohort comprised nearly 100 000 women with baseline ages ranging from 40 to 65 years.

Follow-up questionnaires were sent approximately every 2-3 years after the baseline and addressed general and lifestyle characteristics together with medical events (cancer, cardiovascular diseases, diabetes, depression, fractures and asthma, among others). The follow-up questionnaire response rate remained stable at approximately 80%.

A biological material bank was generated and included blood samples collected from 25 000 women and saliva samples from an additional 47 000 women.

Ageing among the E3N cohort provided the opportunity to investigate factors related to agerelated diseases and conditions as well as disease survival.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Asthma Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Breast Diseases Breast Neoplasms Bronchial Diseases Cardiovascular Diseases Central Nervous System Diseases Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Crohn Disease Depression Diabetes Diabetes Mellitus Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Glucose Metabolism Disorders Head and Neck Neoplasms Hypersensitivity Hypersensitivity, Immediate Hypertension Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Diseases, Obstructive Melanoma Metabolic Diseases Movement Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Nervous System Diseases Neurodegenerative Diseases Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nutritional and Metabolic Diseases Parkinson Disease Parkinsonian Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Synucleinopathies Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms Vascular Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Villejuif, 94800, France

About this study

Who is in the cohort? In June 1990, a questionnaire was sent to 500 000 women who had been born between 1925 and 1950 and were insured by the Mutuelle Générale de l'Education Nationale (MGEN), a national health insurance plan that primarily covers teachers. The questionnaire was sent along with a leaflet explaining that an Inserm research team was launching a study of cancer risk factors and that participation would require filling in questionnaires every 2-3 years as well as the submission of a signed consent form providing permission to obtain information about each participant's vital status, address changes and medical expense reimbursements from the insurance plan. Nearly 100 000 women volunteered.

How often have they been followed-up? Until now, nine follow-up questionnaires have been sent every 2-3 years from the baseline. Approximately half of the answers were obtained after the first mailing. Two reminders were sent thereafter. The questionnaires were accompanied with newsletters that informed participants about the major results obtained to date. The participation rate remained high (77-92% according to the questionnaires) and the lost to follow-up rate was minimal because of the ability to trace non-respondents through their insurance plan files. The questionnaires were accurately filled in, with few missing or unacceptable answers.

What has been measured? To date, 11 self-administered questionnaires have been sent. The collected data are sociodemographic factors, anthropometric measurements, reproductive factors, hormonal treatments, health behaviour and lifestyle. Each follow-up questionnaire also recorded the participant's health status. The questionnaires are available at www.e3n.fr .

The questionnaires are anonymous and identified with an identification number and pin code that can be rapidly scanned to identify the respondents. The questionnaires are optically scanned and all answers are checked on screen. The scanned images are saved to allow data entry at a later time, including information regarding the addresses of medical doctors (18 000 to date) or drug names (pre-listed to avoid errors). The longitudinal data (repeats of identical questions for the purpose of updating information about topics such as menopause or smoking) are routinely homogenized. Several validation studies (e.g. dietary and anthropometrical data studies) have been performed and have revealed very satisfactory results.

Self-reported cases of cancer are validated and coded after reviewing the pathology reports obtained from medical practitioners, and nearly 90% of all cancer cases are histologically confirmed. Other diseases are also validated (e.g. diabetes, myocardial infarction, stroke, Parkinson disease) by requesting additional information about the participants (e.g. glycosylated haemoglobin levels, fracture-related circumstances, drug names) and sending questionnaires to medical doctors.

Additionally, a biological material bank was generated. Blood samples were initially collected from 1994-99. The participation rate among the invited participants was approximately 40%; this yielded approximately 25 000 blood samples that were each separated into 28 aliquots (e.g. plasma, serum, leukocytes, erythrocytes). Plastic straws were used to store each participant's samples in liquid nitrogen containers. The bio-repositories are located at the IARC (Lyon) and the EFS (Etablissement Français du Sang, Annemasse). Since 2004, approximately 10 case-control studies have been conducted (approximately 1 800 cases and 3 500 controls) with regard to the measurements of various biomarkers (e.g. fatty acids, calcium, vitamin D, vitamin B, cholesterol and C-reactive protein). A metabolomics study is currently ongoing.

From 2009-11, saliva samples (Oragene, DNA Genotek, Kanata, ON, Canada) were requested from 68 242 living women and were obtained from 47 000 women (participation rate, 69%). Salivary DNA has been extracted and has been used for genotyping in two case-control studies (approximately 2 500 cases and 850 controls) since December 2010.

The research team is currently planning to set up a tumour tissue bank and will begin with the collection of breast cancer tissues.

What has it found? The E3N cohort has produced a spectrum of results regarding the complex roles played by nutrition, hormonal factors, physical activity, anthropometric characteristics and other major lifestyle-related factors with respect to various diseases.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • only women
  • born between 1925 and 1950
  • insured by the Mutuelle Générale de l'Education Nationale (MGEN)

Exclusion criteria

  • men

Treatment and study plan

Primary outcomes

  1. Anthropometric measurements

    Time frame: From 1990 until now

    Height, weight, hip circumference and waist circumference

  2. Educational level

    Time frame: 1990

  3. Professional activity

    Time frame: 1992 and 2005

    Insee categories

  4. Age at cessation of activity

    Time frame: From 2005 until now

  5. Menstrual factors

    Time frame: From 1990 to 2002

    Age at menarche, length of menstrual cycle

  6. Reproductive history

    Time frame: From 1990 to 1992

    Number of pregnancies, age at each pregnancy, durations and outcomes of pregnancies, breastfeeding, infertility

  7. Menopause

    Time frame: 1990, 1995, 1997, 2000, 2002, 2005

    Age, type

  8. Hormonal Treatments

    Time frame: From 1992 to 2008

    Menopausal Hormonal Treatments (MHT), oral contraceptives

  9. Tobacco consumption

    Time frame: From 1990 until now

    Type, quantity, time of smoking

  10. Alcohol consumption

    Time frame: 1993, 1997, 2005

    Type of alcohol, quantity

  11. Physical activity

    Time frame: 1990,1997,2002, 2005, 2014

    Moderate and intense activity, sedentarity

  12. Diet questionnaire

    Time frame: 1993 and 2002

    Precise annual diet questionnaire

  13. Family history of diseases

    Time frame: 1990 to 2005

    Cancer, diabetes and cardiovascular diseases

  14. Medication use

    Time frame: From 1990 until now

    linked with the drug reimbursement files from the health insurance

  15. Medical and surgical history

    Time frame: From 1990 until now

  16. Mental Health

    Time frame: From 1990 until now

    Centre for Epidemiologic Studies Depression Scale (CESD) and Depression

  17. Health outcomes

    Time frame: From 1990 until now

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris
  • Ligue contre le cancer, France
  • Université Paris-Sud

Registry information

Official study title

The French E3N Prospective Cohort Study (Etude Epidémiologique auprès de Femmes de la Mutuelle Générale de l'Education Nationale)

Acronym: E3N

Important dates

Study start
1990
Primary completion
1991
Study completion
2046
First posted
Sep 15, 2017
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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