Last update : 08/17/2016 | Version : 1 | ID : 33513
General | |
Identification | |
Detailed name | Case-Control Study on the Relationship Between Environmental, Domestic and Occupational Exposure during Early Life, and the Risk of Germ Cell Testicular Cancer in Adulthood |
Sign or acronym | TESTIS |
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP: Favourable opinion of 11 March 2014 (A14-94) and ANSM approval on 24 February 2014 (140184B-12) |
General Aspects | |
Medical area |
Cancer research |
Health determinants |
Climate Genetic Geography Lifestyle and behavior Occupation |
Keywords | multiple exposure, endocrine disruptors, environment, pesticides, risk factors |
Scientific investigator(s) (Contact) | |
Name of the director | Fervers |
Surname | Béatrice |
Address | 28 rue Laennec, 69373 Lyon |
beatrice.fervers@lyon.unicancer.fr | |
Unit | Unité « Cancer et Environnement » |
Organization | Léon Bérard Centre; Claude Bernard University, Lyon |
Name of the director | Beranger |
Surname | Rémi |
Address | 28 rue Laennec, 69373 Lyon |
Phone | +33 (0)4 26 55 68 04 |
remi.beranger@lyon.unicancer.fr | |
Unit | Cancer and Environment Unit |
Organization | Léon Bérard Centre; Claude Bernard University Lyon 1; International Research Centre |
Name of the director | Pérol |
Surname | Olivia |
Address | 28 rue Laennec, 69373 Lyon |
Phone | +33 (0)4 78 78 28 97 |
olivia.perol@lyon.unicancer.fr | |
Unit | Cancer and Environment Unit |
Organization | Léon Centre |
Collaborations | |
Funding | |
Funding status |
Public |
Details | Inserm (National Institute of Health and Medical Research) - INCa (National Cancer Institute) |
Governance of the database | |
Sponsor(s) or organisation(s) responsible | Léon Bérard Centre |
Organisation status |
Public |
Additional contact | |
Main features | |
Type of database | |
Type of database |
Study databases |
Study databases (details) |
Case control study |
Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
Database recruitment is carried out as part of an interventional study |
No |
Additional information regarding sample selection. | Subjects were recruited from Human Embryo and Sperm Conservation and Study Centres (Besançon, Bordeaux, Caen, Clermont-Ferrand, Dijon, Grenoble, Lille, Lyon, Marseilles, Montpellier, Nancy, Nice, Paris Tenon, Paris Jean-Verdier, Paris Cochin, Reims, Rennes, Rouen, Strasbourg, Toulouse, Tours). |
Database objective | |
Main objective |
Main aim: To study the relationship between various exposures, especially to pesticides, during critically sensitive periods in testicular development (pre-conception, intrauterine and early childhood) and the risk of developing testicular cancer in adulthood. Environmental, occupational and domestic exposure will be taken into account in this assessment.
Secondary objectives: To investigate the hypothesis of a dual impact (early life and adulthood) by studying the relationship between various exposures (occupational, environmental and domestic) until adulthood and the risk of developing testicular cancer. To study genetic polymorphisms that may be potentially related to TGCT in the literature, as well as the interactions between these polymorphisms and environmental risk factors, including polymorphisms linked to the metabolic pathways of organochlorine pesticides. |
Inclusion criteria |
Inclusion criteria:
Case subjects and controls must meet the following criteria to be included: – Males aged between 18 and 44 – Born in metropolitan France – Can understand, read and write French – No psychiatric illness or severe cognitive disorder – Volunteered for the study and signed an informed consent – Member of a social security scheme. Exclusion criteria: – Males under temporary guardianship – History of TGCT or cryptorchidism (only for controls). |
Population type | |
Age |
Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) |
Population covered |
General population |
Gender |
Male |
Geography area |
National |
Detail of the geography area | Metropolitan France |
Data collection | |
Dates | |
Date of first collection (YYYY or MM/YYYY) | 01/2015 |
Size of the database | |
Size of the database (number of individuals) |
[1000-10 000[ individuals |
Details of the number of individuals | 1,500 subjects – 500 cases – 1,000 controls |
Data | |
Database activity |
Current data collection |
Type of data collected |
Declarative data Biological data |
Declarative data (detail) |
Phone interview |
Details of collected declarative data | Occupational history of the subject; his/her father (1 year before pregnancy until the child is 17 years old); his/her mother (beginning of professional career until the child is 17 years old); full residential history and domestic exposures. |
Biological data (detail) | Blood sample |
Presence of a biobank |
Yes |
Contents of biobank |
Whole blood Plasma DNA |
Details of biobank content | The sample includes two 7-mL blood collection tubes (1 EDTA and 1 heparin tube) in order to collect the buffy coat and plasma. |
Health parameters studied |
Health event/morbidity |
Procedures | |
Data collection method | Blind telephone interview conducted by a professional investigator where subject case or control are unknown. |
Participant monitoring |
No |
Links to administrative sources |
No |
Promotion and access | |
Promotion | |
Access | |
Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
Access to aggregated data |
Access on specific project only |
Access to individual data |
Access on specific project only |
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