AMEL - Observational study of the management of metastatic melanoma in France
Head :
Godard Chloé, MSD France
Last update : 10/19/2017 | Version : 1 | ID : 73340
| General | |
| Identification | |
| Detailed name | Observational study of the management of metastatic melanoma in France |
| Sign or acronym | AMEL |
| General Aspects | |
| Medical area |
Cancer research |
| Pathology (details) | metastatic melanoma |
| Scientific investigator(s) (Contact) | |
| Name of the director | Godard |
| Surname | Chloé |
| Address |
34 avenue Léonard de Vinci 92418 Courbevoie cedex |
| chloe.godard@merck.com | |
| Unit | MSD France |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | MSD France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | MSD France |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database objective | |
| Main objective | Describe the sociodemographic and clinical profile of patients with metastatic melanoma as well as their therapeutic management |
| Inclusion criteria |
Inclusion criteria:
• History of histopathologically confirmed diagnosis of cutaneous melanoma • Unresectable stage III (per treating physician) or stage IV melanoma according to AJCC (2009) classification at diagnosis or upon progression following diagnosis • Subject’s index date is between 1 January 2012 and 31 October 2012. • Age >= 18 years at the index date • Access to the complete records from the index date until the end of the data extraction period or death whichever is earlier Non-inclusion criteria: • Patients with primary non-cutaneous melanoma including primary ocular melanoma • Patients with an index date before 1 January 2012 and 31 October 2012. • Patients with resectable melanoma who have not relapsed |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Pathology | C00-C97 - Malignant neoplasms |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | no information about the individual |
| Data collection | |
| Dates | |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 271 patients included |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Administrative data Cost data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
No |
| Procedures | |
| Participant monitoring |
No |
| Followed pathology | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | No data access charter |
| Access to aggregated data |
Access not yet planned |
| Access to individual data |
No access |
