SAGHE - Adult Health Childhood GH
Head :
Carel Jean-Claude, CENTRE DE REFERENCE MALADIES ENDOCRINIENNES RARES DE LA CROISSANCE MINISTERE DE LA SANTÉ. AP-HP
Last update : 07/21/2015 | Version : 2 | ID : 60178
| General | |
| Identification | |
| Detailed name | Adult Health Childhood GH |
| Sign or acronym | SAGHE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 18/07/2007 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Health determinants |
Occupation |
| Keywords | Socio-professional insertion |
| Scientific investigator(s) (Contact) | |
| Name of the director | Carel |
| Surname | Jean-Claude |
| Address | PARIS |
| Phone | + 33 (0)1 40 03 41 05 |
| jean-claude.carel@rdb.aphp.fr | |
| Unit | CENTRE DE REFERENCE MALADIES ENDOCRINIENNES RARES DE LA CROISSANCE MINISTERE DE LA SANTÉ. AP-HP |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | AFSSAPS, DGS, INCA, FP7 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | HOPITAL ROBERT DEBRÉ |
| Organisation status |
Public |
| 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 is made on the basis of: |
Medication(s) taken |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Retrospective Inclusion cut-off date: 01/12/1997 |
| Database objective | |
| Main objective | To resolve outstanding issues concerning growth hormone deficiency, Turner's syndrome and patients treated with growth hormone. Secondary objectives: - To explain the frequency and severity of hormonal, metabolic, skeletal, and cardiovascular events during life as well as their determinants. - To identify patient subgroups according to the severity and their phenotypic and/or genetic characteristics in relation to both French molecular genetics laboratories, hospitals and INSERM for developmental pituitary gland abnormalities. - To better understand patient outcome in terms of education, social and professional insertion and psychological impact. - To improve appropriate treatment strategies during childhood and the transition into adulthood. - To reassess the long-term effectiveness of growth hormone treatment for growth hormone deficiency. Several questions remain outstanding, in addition to high cost, the effectiveness on final height as well as the quality of life for a significant number of patients. - To monitor long-term tolerance with particular focus on tumour risk |
| Inclusion criteria | Patients treated with recombinant growth hormone in childhood from 1985 to 1997. |
| Population type | |
| Age |
Newborns (birth to 28 days) Childhood (6 to 13 years) Adolescence (13 to 18 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 20 centres throughout France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1985 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 10 489 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data Paraclinical data |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Paraclinical data (detail) | Imaging |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation |
| Procedures | |
| Data collection method | Self-administered questionnaire: manual input from a paper questionnaire with double data entry |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Duration: 30 years |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | CépiDc, RNIAM (MINISTERIAL DECREE OF 4TH MARCH 2008, PUBLISHED IN THE OJ ON 15TH MARCH 2008) |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/HAL-SAGHE |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=SAGHE+AND+Carel[author] |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided if data may be used by academic teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
