The French E3N Prospective Cohort Study (E3N)
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| ClinicalTrials.gov Identifier: NCT03285230 |
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Recruitment Status :
Active, not recruiting
First Posted : September 15, 2017
Last Update Posted : September 19, 2017
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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 |
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| 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
| 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 |
- Anthropometric measurements [ Time Frame: From 1990 until now ]Height, weight, hip circumference and waist circumference
- Educational level [ Time Frame: 1990 ]
- Professional activity [ Time Frame: 1992 and 2005 ]Insee categories
- Age at cessation of activity [ Time Frame: From 2005 until now ]
- Menstrual factors [ Time Frame: From 1990 to 2002 ]Age at menarche, length of menstrual cycle
- Reproductive history [ Time Frame: From 1990 to 1992 ]Number of pregnancies, age at each pregnancy, durations and outcomes of pregnancies, breastfeeding, infertility
- Menopause [ Time Frame: 1990, 1995, 1997, 2000, 2002, 2005 ]Age, type
- Hormonal Treatments [ Time Frame: From 1992 to 2008 ]Menopausal Hormonal Treatments (MHT), oral contraceptives
- Tobacco consumption [ Time Frame: From 1990 until now ]Type, quantity, time of smoking
- Alcohol consumption [ Time Frame: 1993, 1997, 2005 ]Type of alcohol, quantity
- Physical activity [ Time Frame: 1990,1997,2002, 2005, 2014 ]Moderate and intense activity, sedentarity
- Diet questionnaire [ Time Frame: 1993 and 2002 ]Precise annual diet questionnaire
- Family history of diseases [ Time Frame: 1990 to 2005 ]Cancer, diabetes and cardiovascular diseases
- Medication use [ Time Frame: From 1990 until now ]linked with the drug reimbursement files from the health insurance
- Medical and surgical history [ Time Frame: From 1990 until now ]
- Mental Health [ Time Frame: From 1990 until now ]Centre for Epidemiologic Studies Depression Scale (CESD) and Depression
- Health outcomes [ Time Frame: From 1990 until now ]
Biospecimen Retention: Samples With DNA
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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 |
Inclusion Criteria:
- only women
- born between 1925 and 1950
- insured by the Mutuelle Générale de l'Education Nationale (MGEN)
Exclusion Criteria:
- men
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
| 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:
| 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 |
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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 |