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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

  Show Detailed Description

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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