ITMO public health
Last update : 07/08/2015 | Version : 3 | ID : 77
| General | |
| Identification | |
| Detailed name | The Genetics and Neuroendocrinology of Short Stature International study |
| Sign or acronym | GeNesis |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N° 999310 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Genetic |
| Keywords | Growth retardation, auxological measurements, relative efficacy in actual life, children, treatment, tolerance |
| Scientific investigator(s) (Contact) | |
| Name of the director | Médecin pharmacoépidémiologiste |
| fr_mail_pharmacoepi@lilly.com | |
| Unit | Eli Lilly France |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Eli Lilly and Company |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Eli Lilly |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort 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. | For France: recruitment of patients by endocrinologists, pediatricians and pediatric endocrinologists involved in caring for children with a growth disorder and in prescribing growth hormone treatments and located all across the territory |
| Database objective | |
| Main objective | Evaluate the safety and effectiveness of the treatment via recombinant human growth hormone (Humatrope) using observation data. |
| Inclusion criteria | Children having a growth disorders whether or not treated via somatropin |
| Population type | |
| Age |
Childhood (6 to 13 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | about 30 countries |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2000 |
| Date of last collection (YYYY or MM/YYYY) | 2015 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 9697 (03/10/2012) |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Biological data (detail) | Fasting glucose, biochemical indicators of the secretion of GH, hormone assays, urine bone marker assays, IGF-1 and IGFBP-3 assays |
| Presence of a biobank |
Yes |
| Contents of biobank |
DNA |
| Details of biobank content | non-systematic biobank |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Data collection notebook |
| Participant monitoring |
Yes |
| Details on monitoring of participants | follow-up until final size |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/GENESIS |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-Cohorte-GENESIS |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Report and publication |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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