EPICAP - Case-Control Study of Subjects Under 75 Years Old with Prostate Cancer: The Role of Genetic and Environmental Risk Factors
Head :
Menegaux Florence, INSERM U1018 - CESP - Environmental Cancer Epidemiology Unit
Last update : 09/06/2017 | Version : 1 | ID : 5914
| General | |
| Identification | |
| Detailed name | Case-Control Study of Subjects Under 75 Years Old with Prostate Cancer: The Role of Genetic and Environmental Risk Factors |
| Sign or acronym | EPICAP |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL no. 910485 (11/04/2011) - INSERM IRB no. 01-040 (17/11/2010) |
| General Aspects | |
| Medical area |
Cancer research |
| Pathology (details) | chronic inflammation, hormonal and metabolic factors, circadian rhythm |
| Health determinants |
Genetic Occupation |
| Scientific investigator(s) (Contact) | |
| Name of the director | Menegaux |
| Surname | Florence |
| Address | 16 av. Paul Vaillant Couturier - 94800 Villejuif |
| Phone | + 33 (0)1 45 59 51 53 |
| florence.menegaux@inserm.fr | |
| Unit | INSERM U1018 - CESP - Environmental Cancer Epidemiology Unit |
| Organization | INSERM - Institut National de Santé et Recherche |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | PRACTICAL Consortium |
| Funding | |
| Funding status |
Mixed |
| Details | Regional French National League Against Cancer (LNCC) in Val-du-Marne, French Foundation, ANSES. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM - Institut National de Santé et Recherche Médicale |
| 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. | Individuals meeting the exclusion criteria. |
| Database objective | |
| Main objective | To investigate the role of environmental and genetic risk factors of prostate cancer. |
| Inclusion criteria |
Cases: all patients newly diagnosed with prostate cancer in 2012-2013, under 75 years old and residing in Hérault.
Controls: males under 75 years old, residing in Hérault, who are the same age as the case subjects and free from prostate cancer. |
| Population type | |
| Age |
Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
General population |
| Gender |
Male |
| Geography area |
Departmental |
| French regions covered by the database |
Languedoc-Roussillon Midi-Pyrénées |
| Detail of the geography area | Hérault |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/2012 |
| Date of last collection (YYYY or MM/YYYY) | 12/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 819 cases/ 879controls |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | ----- |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Details of collected declarative data | ----- |
| Biological data (detail) | Blood sample (EDTA and dry tubes) or, failing this, a saliva sample. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Plasma DNA |
| Details of biobank content | Samples managed by the Epigenetec Paris St-Pères BRCs and specialised biology laboratory in Montpellier. |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Only for cases. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | Database access conditions are currently being determined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
