NCT03285230

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 1990

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 1990

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 1991

Completed
25.7 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
8.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

July 27, 2017

Last Update Submit

September 18, 2017

Conditions

Outcome Measures

Primary Outcomes (17)

  • Anthropometric measurements

    Height, weight, hip circumference and waist circumference

    From 1990 until now

  • Educational level

    1990

  • Professional activity

    Insee categories

    1992 and 2005

  • Age at cessation of activity

    From 2005 until now

  • Menstrual factors

    Age at menarche, length of menstrual cycle

    From 1990 to 2002

  • Reproductive history

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

    From 1990 to 1992

  • Menopause

    Age, type

    1990, 1995, 1997, 2000, 2002, 2005

  • Hormonal Treatments

    Menopausal Hormonal Treatments (MHT), oral contraceptives

    From 1992 to 2008

  • Tobacco consumption

    Type, quantity, time of smoking

    From 1990 until now

  • Alcohol consumption

    Type of alcohol, quantity

    1993, 1997, 2005

  • Physical activity

    Moderate and intense activity, sedentarity

    1990,1997,2002, 2005, 2014

  • Diet questionnaire

    Precise annual diet questionnaire

    1993 and 2002

  • Family history of diseases

    Cancer, diabetes and cardiovascular diseases

    1990 to 2005

  • Medication use

    linked with the drug reimbursement files from the health insurance

    From 1990 until now

  • Medical and surgical history

    From 1990 until now

  • Mental Health

    Centre for Epidemiologic Studies Depression Scale (CESD) and Depression

    From 1990 until now

  • Health outcomes

    From 1990 until now

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

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

You may not qualify if:

  • \- men

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

  • Clavel-Chapelon F; E3N Study Group. Cohort Profile: The French E3N Cohort Study. Int J Epidemiol. 2015 Jun;44(3):801-9. doi: 10.1093/ije/dyu184. Epub 2014 Sep 10.

    PMID: 25212479BACKGROUND
  • Dusser P, Nguyen Y, Perrin C, Frenoy P, Mariette X, Boutron-Ruault MC, Varraso R, Severi G, Salliot C, Seror R. Early-life animal and farming exposures and the risk of rheumatoid arthritis: findings from the E3N French cohort study. RMD Open. 2025 Dec 7;11(4):e005954. doi: 10.1136/rmdopen-2025-005954.

  • Auguste A, Jansana A, Freisling H, Ferrari P, Laouali N, Severi G, Kvaskoff M. Impact of Hypertension on Cancer Stage at Diagnosis Among French Women: The E3N Prospective Cohort. Cancer Med. 2025 Aug;14(15):e71021. doi: 10.1002/cam4.71021.

  • Klu YE, Amazouz H, Canonico M, Guenel P, Kvaskoff M, Severi G, Radoi L, Auguste A. Association Between Hormonal Factors and Risk of Lung and Upper Aerodigestive Tract Cancer in French Women: The E3N Prospective Cohort Study. Cancer Rep (Hoboken). 2025 Jun;8(6):e70223. doi: 10.1002/cnr2.70223.

  • Koemel NA, Shah S, Senior AM, Severi G, Mancini FR, Gill TP, Simpson SJ, Raubenheimer D, Boutron-Ruault MC, Laouali N, Skilton MR. Macronutrient composition of plant-based diets and breast cancer risk: the E3N prospective cohort study. Eur J Nutr. 2024 Aug;63(5):1771-1781. doi: 10.1007/s00394-024-03379-x. Epub 2024 Apr 18.

  • Shah S, Mahamat-Saleh Y, Ait-Hadad W, Koemel NA, Varraso R, Boutron-Ruault MC, Laouali N. Long-term adherence to healthful and unhealthful plant-based diets and breast cancer risk overall and by hormone receptor and histologic subtypes among postmenopausal females. Am J Clin Nutr. 2023 Mar;117(3):467-476. doi: 10.1016/j.ajcnut.2022.11.019.

  • Shah S, Mahamat-Saleh Y, Hajji-Louati M, Correia E, Oulhote Y, Boutron-Ruault MC, Laouali N. Palaeolithic diet score and risk of breast cancer among postmenopausal women overall and by hormone receptor and histologic subtypes. Eur J Clin Nutr. 2023 May;77(5):596-602. doi: 10.1038/s41430-023-01267-x. Epub 2023 Feb 1.

  • Frenoy P, Perduca V, Cano-Sancho G, Antignac JP, Severi G, Mancini FR. Application of two statistical approaches (Bayesian Kernel Machine Regression and Principal Component Regression) to assess breast cancer risk in association to exposure to mixtures of brominated flame retardants and per- and polyfluorinated alkylated substances in the E3N cohort. Environ Health. 2022 Feb 26;21(1):27. doi: 10.1186/s12940-022-00840-4.

  • Madika AL, MacDonald CJ, Gelot A, Hitier S, Mounier-Vehier C, Beraud G, Kvaskoff M, Boutron-Ruault MC, Bonnet F. Hysterectomy, non-malignant gynecological diseases, and the risk of incident hypertension: The E3N prospective cohort. Maturitas. 2021 Aug;150:22-29. doi: 10.1016/j.maturitas.2021.06.001. Epub 2021 Jun 12.

  • Laouali N, Shah S, MacDonald CJ, Mahamat-Saleh Y, El Fatouhi D, Mancini F, Fagherazzi G, Boutron-Ruault MC. BMI in the Associations of Plant-Based Diets with Type 2 Diabetes and Hypertension Risks in Women: The E3N Prospective Cohort Study. J Nutr. 2021 Sep 4;151(9):2731-2740. doi: 10.1093/jn/nxab158.

  • Cairat M, Al Rahmoun M, Gunter MJ, Severi G, Dossus L, Fournier A. Antiplatelet Drug Use and Breast Cancer Risk in a Prospective Cohort of Postmenopausal Women. Cancer Epidemiol Biomarkers Prev. 2021 Apr;30(4):643-652. doi: 10.1158/1055-9965.EPI-20-1292. Epub 2021 Feb 2.

  • Azevedo Da Silva M, Fournier A, Boutron-Ruault MC, Balkau B, Bonnet F, Nabi H, Fagherazzi G. Increased risk of type 2 diabetes in antidepressant users: evidence from a 6-year longitudinal study in the E3N cohort. Diabet Med. 2020 Nov;37(11):1866-1873. doi: 10.1111/dme.14345. Epub 2020 Jul 2.

  • Mahamat-Saleh Y, Cervenka I, Al Rahmoun M, Savoye I, Mancini FR, Trichopoulou A, Boutron-Ruault MC, Kvaskoff M. Mediterranean dietary pattern and skin cancer risk: A prospective cohort study in French women. Am J Clin Nutr. 2019 Oct 1;110(4):993-1002. doi: 10.1093/ajcn/nqz173.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

25000 blood samples; 47000 saliva samples

MeSH Terms

Conditions

Breast NeoplasmsColonic NeoplasmsParkinson DiseaseAsthmaDiabetes MellitusInflammatory Bowel DiseasesMelanomaEndometriosisThyroid NeoplasmsHypertensionEndometrial NeoplasmsCrohn DiseaseDepressionCardiovascular Diseases

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesGastroenteritisNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsThyroid DiseasesVascular DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesBehavioral SymptomsBehavior

Study Officials

  • Gianluca Severi, PhD

    INSERM (Institut National de la Sante et de la Recherche Medicale)

    STUDY DIRECTOR
  • Marie-Christine Boutron-Ruault, PhD

    INSERM (Institut National de la Sante et de la Recherche Medicale)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

September 15, 2017

Study Start

June 15, 1990

Primary Completion

November 15, 1991

Study Completion

December 15, 2025

Last Updated

September 19, 2017

Record last verified: 2017-09