Call for proposals to open access to databases, including the biological collection from the 2014–2016 Esteban study

The purpose of this call for proposals is to make the databases and associated biological collection from the 2014–2016 Esteban study available to the scientific community.

SURVEYS/STUDIES

Esteban

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As part of the national biomonitoring program and its monitoring activities, Santé publique France conducted a survey including health examinations among the general population: the Esteban study (Health Study on the Environment, Biomonitoring, Physical Activity, and Nutrition).

The scientific direction of this study is guided by a scientific advisory board composed of experts from outside Santé publique France in the fields of exposometrics, metrology, analytical chemistry, epidemiology, toxicology, and statistics.

Through this call for proposals, Santé publique France aims to make the databases and the associated biological collection (excluding a small specific reserve) available to the scientific community to enable the implementation of projects involving complementary analyses, once the main objectives of the Esteban study have been achieved.

For further details regarding the submission of a request for access to the data and/or the biological collection, interested scientific teams are invited to contact the designated representative listed below according to the topic:

Once initial contact has been made, teams wishing to use these data may submit an access request (objective, justification, planned analyses, required data) using the downloadable document: “Fiche_projet_soumission_Etude Esteban,” to be sent to the email address: aap_esteban@santepubliquefrance.fr. Projects submitted using this form must detail the objectives and epidemiological context of the planned analyses.

Project proposals will be selected by the Esteban Study’s Scientific Advisory Board (SAB), with input from experts outside the SAB if necessary. The selection process will consider the scientific and public health value of the request, its relevance, feasibility, and ethical and regulatory requirements. In this regard, access to personal data will comply with the conditions set forth by the French Data Protection Act1. Similarly, requests for access to personal data from the SNDS will comply with the provisions of the Public Health Code2.

The decision regarding data access for the requesting team will be issued within 3 months. An agreement (license or contract) for data use, specifying the conditions and duration of use, will be signed between Santé publique France and the requesting team.

Access to the databases is free of charge. However, costs associated with accessing and using the Esteban biological collection are the responsibility of the requesting team. Technical support regarding data use will be provided to teams authorized to use the data by the Santé publique France research team.

Use of the Esteban biological collection must comply with the conditions set forth in the consent agreement, namely, it must involve conducting assays to address questions in the fields of chronic diseases, nutrition, or human biomonitoring.

The transportation of samples from the biobank (Biological Resource Center of the Tours University Hospital) to the laboratories of the requesting teams will be the responsibility of the latter.

The requesting teams agree to conduct the analyses and provide preliminary draft work within a maximum of 3 years from the date the data is transmitted. They must secure funding for their projects. An amendment may be signed by the parties if the project is not completed by the end of the three-year period. However, Santé publique France reserves the right to request the destruction of the data if it determines that, three years after their transmission, the project has not made any significant progress.

In the interest of transparency, Santé publique France will publish on its website the list of projects selected under this call for proposals for which an agreement has been signed between the two parties and data transfer has been completed. Data subjects may, if necessary, object to the reuse of their personal data.

This call for proposals has no end date. Projects will be reviewed as they are received, every three months, starting in February 2020, in accordance with the procedures described above. The database of existing questionnaires and biological measurements will, however, remain accessible in the long term, although we cannot guarantee the availability of whatever remains of the biological collection. Indeed, the acceptance of projects requesting biological samples will gradually reduce the size of the collection.

More information about the study (protocol, questionnaires, study timeline, results, publications, etc.) is available at: https://www.santepubliquefrance.fr/etudes-et-enquetes/esteban

1 Law No. 78-17 of January 6, 1978, on Information Technology, Data Files, and Civil Liberties
2 Article L. 1461-1 et seq.; Article R. 1461-1 et seq. of the Public Health Code and the Order of March 22, 2017, regarding the security framework applicable to the National Health Data System

A recap of the objectives of the Esteban study

These objectives were:

  • to estimate exposure levels to environmental substances with a presumed and/or observed impact on health and to establish reference values;

  • to describe dietary intake, physical activity, sedentary behavior, and nutritional status;

  • to estimate the prevalence of certain chronic diseases or risk factors, as well as the prevalence of atopy, asthma, and allergic diseases.

To this end, each participant completed a “questionnaire survey,” a “food survey” (3 x 24-hour recalls), and underwent a “health examination” comprising a series of measurements (anthropometric, blood pressure, pulmonary function testing for adults) and biological samples (blood, urine, hair). More than a hundred environmental biomarkers (pesticides, metals, phthalates, bisphenols, PAHs, dioxins and PCBs, furans, cotinine, perfluorinated compounds, polybrominated compounds, glycol ethers, parabens, mycotoxins, etc.) and markers of nutritional status (vitamins A, B9, D, E, ferritin, hemoglobin, carotenoids) were measured. IgE levels were also measured in children. Esteban also provided biological data on certain chronic diseases (fasting blood glucose and lipid profile, serum creatinine, hemoglobin, HbA1c).

Data collected via questionnaire covered: sociodemographic and economic data; physical activity and sedentary behavior; diet; residential environment; occupational exposure; lifestyle factors; general health; and healthcare utilization (via the NIR database) among participants. (See the Esteban study protocol article).

The Esteban study included 1,104 children (ages 6–17) and 2,503 adults (ages 18–74) between April 2014 and March 2016 for whom Santé publique France has biological samples of blood, urine, and hair.

Study protocol:

Balicco A, Oleko A, Szego E, Boschat L, Deschamps V, Saoudi A, et al. The Esteban Protocol: A Cross-Sectional Study on Environmental Health, Biomonitoring, Physical Activity, and Nutrition (2014–2016). Analytical & Clinical Toxicology 2017; 29:517-37.

For the “nutrition and diet” component:

Nutritional Surveillance and Epidemiology Team (Esen). Health Study on the Environment, Biomonitoring, Physical Activity, and Nutrition (Esteban), 2014–2016. Nutrition Component. Chapter on Obesity. Saint-Maurice: Santé publique France, 2017. 42 p.

Verdot C, Torres M, Salanave B, Deschamps V. Obesity among children and adults in metropolitan France in 2015. Results of the Esteban study and trends since 2006. Bull Epidémiol Hebd. 2017;(13):234-41.

Nutritional Surveillance and Epidemiology Team (Esen). Health Study on the Environment, Biomonitoring, Physical Activity, and Nutrition (Esteban) 2014–2016. Nutrition Section. Chapter on Physical Activity and Sedentary Behavior. Saint-Maurice: Santé publique France, 2017. 58 p.

Nutrition Surveillance and Epidemiology Team (Esen). Health Study on the Environment, Biomonitoring, Physical Activity, and Nutrition (Esteban), 2014–2016. Nutrition Section. Chapter on Food Consumption. Saint-Maurice: Santé publique France, 2017. 193 p.

Torres MJ, Salanave B, Verdot C, Deschamps V. Compliance with the new dietary recommendations among adults aged 18 to 54 living in France. Esteban Study 2014–2016. Nutrition Module – Epidemiological Surveillance. Saint-Maurice: Public Health France; 2019. 8 p.

For the “chronic diseases” component:

Clara Piffaretti, Sonsoles Fuentes, Hadja Djessira Nabe, Sofiane Kab, Amivi Oleko, Emmanuel Cosson, Sandrine Fosse Edorh “Prediabetes and undiagnosed diabetes prevalence in two French nationwide studies: Esteban, Constances.” European Diabetes Epidemiology Group (EDEG) Annual Meeting. May 11–14, 2019.

Vallée A, Gabet A, Blacher J, Olié V. Patterns of hypertension management in France in 2015: the ESTEBAN survey (Submitted)

Vallée A, Olié V, Lelong H, Kretz S, Safar ME, Blacher J. Relationship between BMI and aortic stiffness: influence of anthropometric indices in hypertensive patients (submitted to Journal of Hypertension)

Blacher J, Gabet A, Vallée A, Ferrières J, Bruckert E, Farnier M, Olié V. Hypercholesterolemia in France. From recommendations to real-life management: the French gap. (Submitted to Circulation)

Vallée A, Gabet A, Deschamps V, Blacher J, Olié V. Relationship between Nutrition and Alcohol Consumption and Blood Pressure: The ESTEBAN Survey. Nutrients 2019, 11, 1433.

Vallée A, Perrine AL, Deschamps V, Blacher J, Olié V. Relationship between dynamic changes in body weight and blood pressure: the ESTEBAN survey. Am J Hypertens. 2019 Jun 18

Lecoffre C, Perrine AL, Jacques Blacher J, Olié V. LDL cholesterol in adults in mainland France: average concentration, awareness, and treatment in 2015, and trends since 2006. Bull Epidémiol Hebd. 2018;(37):710-19.

Perrine AL, Lecoffre C, Blacher J, Olié V. Hypertension in France: prevalence, treatment, and control in 2015 and trends since 2006. Bull Epidemiol Hebd. 2018;(10):170-9.

Delépierre Julie. Links between exposure to environmental pollutants and the risk of diabetes or prediabetes in the French adult population. Master’s 2 in Methodology and Statistics in Biomedical Research, Paris-Sud University, Academic Year 2018-2019.

For the “biomonitoring” component

Romuald Tagne-Fotso, Abdessatar Saoudi, Abdelkrim Zeghnoun, Amivi Oleko, Jessica Gane, Marie-Laure Bidondo, Sébastien Denys, Clémence Fillol, Alexis Balicco. Bisphenol (A, F, S) exposure levels in the French population aged 6 to 74 years in 2014-2016: The Esteban study. ISES ISIAQ 2019 Meeting.

Amivi OLEKO, Clemence FILLOL, Abdessattar SAOUDI, Abdelkrim ZEGHNOUN, Marie Laure BIDONDO, Jessica GANE, Alexis BALICCO, Emmanuelle SZEGO, Sebastien DENYS. Exposure levels to brominated flame retardants and perfluorinated compounds in the French nationwide study: Esteban 2014–2016. ISBM-11, 2019.

Alexis BALICCO, Amivi OLEKO, Romuald TAGNE FOTSO, Abdessatar SAOUDI, Abdelkrim ZEGHNOUN, Jessica GANE, Marie-Laure BIDONDO, Sébastien DENYS, Clémence FILLOL. Bisphenol and phthalate exposure levels in the French population aged 6 to 74 years in 2014–2016: The Esteban study. ISBM-11, 2019.

Exposure of the French population to bisphenols A, S, and F. National Biomonitoring Program, Esteban 2014–2016. Saint-Maurice: Santé publique France, September 2019. 57 p. Available at: www.santepubliquefrance.fr.

Exposure of the French population to phthalates. National Biomonitoring Program, Esteban 2014-2016. Saint-Maurice: Santé publique France, September 2019. 51 p.

Exposure of the French population to glycol ethers. National Biomonitoring Program, Esteban 2014–2016. Saint-Maurice: Santé publique France, September 2019. 45 p.

Exposure of the French population to brominated flame retardants. National Biomonitoring Program, Esteban 2014–2016. Saint-Maurice: Santé publique France, September 2019. 61 p.

Exposure of the French population to parabens. National Biomonitoring Program, Esteban 2014-2016. Saint-Maurice: Santé publique France, September 2019. 40 p.

Exposure of the French population to perfluorinated compounds. National Biomonitoring Program, Esteban 2014–2016. Saint-Maurice: Santé publique France, September 2019. 58 p.