跳至主要内容
临床试验/NCT03285230
NCT03285230进行中(未招募)不适用

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

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 1990年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100,000
试验地点
1
主要终点
Diet questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 未提供

结局指标

主要结局

Diet questionnaire

时间窗: 1993 and 2002

Precise annual diet questionnaire

Family history of diseases

时间窗: 1990 to 2005

Cancer, diabetes and cardiovascular diseases

Anthropometric measurements

时间窗: From 1990 until now

Height, weight, hip circumference and waist circumference

Menopause

时间窗: 1990, 1995, 1997, 2000, 2002, 2005

Age, type

Health outcomes

时间窗: From 1990 until now

Mental Health

时间窗: From 1990 until now

Centre for Epidemiologic Studies Depression Scale (CESD) and Depression

Educational level

时间窗: 1990

Reproductive history

时间窗: From 1990 to 1992

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

Age at cessation of activity

时间窗: From 2005 until now

Hormonal Treatments

时间窗: From 1992 to 2008

Menopausal Hormonal Treatments (MHT), oral contraceptives

Physical activity

时间窗: 1990,1997,2002, 2005, 2014

Moderate and intense activity, sedentarity

Medical and surgical history

时间窗: From 1990 until now

Professional activity

时间窗: 1992 and 2005

Insee categories

Menstrual factors

时间窗: From 1990 to 2002

Age at menarche, length of menstrual cycle

Alcohol consumption

时间窗: 1993, 1997, 2005

Type of alcohol, quantity

Tobacco consumption

时间窗: From 1990 until now

Type, quantity, time of smoking

Medication use

时间窗: From 1990 until now

linked with the drug reimbursement files from the health insurance

次要结局

未报告次要终点

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验