ADAGIO - Observational study of the observance of the adjuvant treatment with Taxotere® in the operable breast cancer
Head :
VIGNAL Franck, Sanofi Aventis
Last update : 03/06/2012 | Version : 1 | ID : 81
| General | |
| Identification | |
| Detailed name | Observational study of the observance of the adjuvant treatment with Taxotere® in the operable breast cancer |
| Sign or acronym | ADAGIO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Numéro CNIL = 907177, Numéro CPP = NA, Afssaps = NA |
| General Aspects | |
| Medical area |
Cancer research |
| Others (details) | breast cancer |
| Keywords | docetaxel observance in adjuvant treatment, operable breast cancer that has spread to the lymph nodes. |
| Scientific investigator(s) (Contact) | |
| Name of the director | VIGNAL |
| Surname | Franck |
| Phone | +33 (0)1 57 63 26 47 |
| franck.vignal@sanofi-aventis.com | |
| Unit | Sanofi Aventis |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Sanofi-aventis France |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Sanofi-aventis France |
| 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 |
| Database objective | |
| Main objective | Evaluate the observance of the adjuvant treatment with Taxotere® in the operable breast cancer that has spread to the lymph nodes. |
| Inclusion criteria |
Patients having breast cancer operated on that has spread to the lymph nodes. For whom the decision of a adjuvant chemotherapy with Taxotere® base was taken. Who have given their agreement to participate in the study. |
| 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 |
Woman |
| Geography area |
National |
| Detail of the geography area | Metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 321 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | --- |
| Declarative data (detail) |
Phone interview |
| Details of collected declarative data | --- |
| Biological data (detail) | • Biological-hepatic balance carried out (Yes/No) and where applicable, variable(s) disturbed (transaminases, bilirubin, gamma-GT, alkaline phosphatases), |
| Administrative data (detail) | • Social and occupational category, • Professional activity. • Lost work time (Yes/no) if activity. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | observance of chemo treatment, operable breast cancer |
| Participant monitoring |
Yes |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
