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The French E3N Prospective Cohort Study (E3N)

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ClinicalTrials.gov Identifier: NCT03285230
Recruitment Status : Active, not recruiting
First Posted : September 15, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborators:
Université Paris-Sud
Gustave Roussy, Cancer Campus, Grand Paris
Ligue contre le cancer, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief Summary:

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.


Condition or disease
Breast Cancer Colo-rectal Cancer Parkinson Disease Asthma Diabetes Inflammatory Bowel Diseases Melanoma Endometriosis Thyroid Cancer Hypertension Endometrial Cancer Crohn Disease Depression Cardiovascular Diseases

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Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The French E3N Prospective Cohort Study (Etude Epidémiologique auprès de Femmes de la Mutuelle Générale de l'Education Nationale)
Actual Study Start Date : June 15, 1990
Actual Primary Completion Date : November 15, 1991
Estimated Study Completion Date : December 15, 2025

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
25000 blood samples; 47000 saliva samples


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The cohort comprised nearly 100 000 women with baseline ages ranging from 40 to 65 years, all insured through a French national health system (MGEN).
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- men


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285230


Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Université Paris-Sud
Gustave Roussy, Cancer Campus, Grand Paris
Ligue contre le cancer, France
Investigators
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Study Director: Gianluca Severi, PhD INSERM (Institut National de la Sante et de la Recherche Medicale)
Principal Investigator: Marie-Christine Boutron-Ruault, PhD INSERM (Institut National de la Sante et de la Recherche Medicale)

Additional Information:
Publications:
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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03285230     History of Changes
Other Study ID Numbers: C 95-01
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Endometrial Neoplasms
Thyroid Neoplasms
Colorectal Neoplasms
Crohn Disease
Inflammatory Bowel Diseases
Parkinson Disease
Endometriosis
Cardiovascular Diseases
Neoplasms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Gastroenteritis
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female