HypoCCS - The Global Hypopituitary Control and Complications Study (HypoCCS)-A Global Observational Research Program
Head :
Médecin pharmacoépidémiologiste , Eli Lilly France
Last update : 07/22/2015 | Version : 2 | ID : 78
| General | |
| Identification | |
| Detailed name | The Global Hypopituitary Control and Complications Study (HypoCCS)-A Global Observational Research Program |
| Sign or acronym | HypoCCS |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°903074 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism |
| Keywords | Somatotrope deficiency, adult, treatments, tolerance, quality of life |
| Scientific investigator(s) (Contact) | |
| Name of the director | Médecin pharmacoépidémiologiste |
| 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) |
Longitudinal study (except cohorts) |
| 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. | Patients recruited by endocrinologists |
| Database objective | |
| Main objective | Primary objective: long-term follow-up of the clinical change and of the tolerance in patients with a somatotrope deficiency whether or not treated with somatropin (Umatrope®) |
| Inclusion criteria |
- Adult patients suffering from growth hormone deficiency secondary to a hypothalamic or pituitary disease appearing in adulthood or suffering from a growth hormone deficiency since childhood,
- having terminated their growth (epiphyseal closure), - having no contraindications to the treatment such as are specified in the summary of product characteristics. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | international |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2003 |
| Date of last collection (YYYY or MM/YYYY) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | recruitment closed |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | ECG, MRI, Scanner (if available) |
| Biological data (detail) | IGF-I, lipidic and glycemic profile, hormone assays (if available) |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Quality of life/health perception |
| Procedures | |
| Data collection method | Data collection notebook and questionnaire |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Followed for 10 to 10 years according to the date of inclusion |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-HYPOCCS |
| 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 |
