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

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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

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