FRAME - First-line treatment of non-small cell lung cancer under routine conditions: observational study on overall survival
Head :
Médecin pharmacoépidémiologiste , Eli Lilly France
Last update : 07/22/2015 | Version : 2 | ID : 74
| General | |
| Identification | |
| Detailed name | First-line treatment of non-small cell lung cancer under routine conditions: observational study on overall survival |
| Sign or acronym | FRAME |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL N°909066 |
| General Aspects | |
| Medical area |
Cancer research Pneumology |
| Keywords | Non-small cell lung cancer, first-line chemotherapy, platinum salt, survival, pemetrexed |
| 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) |
Longitudinal study (except cohorts) |
| 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. | Patients recruited by practitioners. Oncologists and pneumologists caring for patients suffering from non-small cell lung cancer. Random selection of practitioners using a professional file. |
| Database objective | |
| Main objective |
Primary objective: evaluate the overall survival of patients with a diagnosis of locally advanced or metastatic non-small cell lung cancer (stage IIIb or IV) initiating first-line chemotherapy combined with a platinum salt, whether or not combined with a targeted agent, in a daily practice setting.
Secondary objectives: - Survival at 1 year, survival without progression and tumor response: according to histological subgroup and whether or not a target edagent is used; - Diagnosis of histopathological/cytopathological subtype; - Care pathway and use of resources. |
| Inclusion criteria |
Have a histopathological or cytopathological diagnosis of locally advanced or metastatic non-small cell lung cancer (stage IIIb or IV).
- Initiate first-line chemotherapy for a non-small cell lung cancer combined with a platinum salt, whether or not combined with a targeted agent. |
| 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 |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | Europe |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 5667 |
| 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) | histology, cytomarkers |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | Study data collection form |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 18 months follow up |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-FRAME |
| 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 |
