CHORALE - Observational study on compliance, social consequences, management and costs of oral therapy in advanced or metastatic ErbB2+ (HER2+) breast cancer

Head :
Leclerc-Zwirn Christel, Laboratoire GSK

Last update : 09/07/2020 | Version : 1 | ID : 149

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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 on compliance, social consequences, management and costs of oral therapy in advanced or metastatic ErbB2+ (HER2+) breast cancer
Sign or acronym CHORALE
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation 1493177
General Aspects
Medical area Cancer research
Pathology (details) economy, social
Health determinants Lifestyle and behavior
Medicine
Occupation
Social and psychosocial factors
Keywords oral therapy, HER2+, Tyverb
Scientific investigator(s) (Contact)
Name of the director Leclerc-Zwirn
Surname Christel
Phone +33 (0)1 39 17 86 96
Email christel.c.leclerc-zwirn@gsk.com
Unit Laboratoire GSK
Collaborations
Funding
Funding status Private
Details GSK laboratory
Governance of the database
Sponsor(s) or organisation(s) responsible Laboratoire GSK
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. Doctors who have accepted to participate in the study will include all eligible patients with a maximum of 7 patients per doctor. Patient-follow-up will be 9 months starting from the day of inclusion, even in the event oral treatment is stopped. Data collection concerning this follow-up after inclusion will be carried out every 3 months during 3 visits carried out in the framework of the normal follow-up of patients
Database objective
Main objective The main objective of this study is to assess the economic and social consequences of oral cancer therapies in patients with advanced or metastatic breast cancer overexpressing Her2
Inclusion criteria • Adult patient with metastatic breast cancer overexpressing Her2
• Patient for whom oral therapy (other than hormone therapy) has to be initiated on the day of inclusion (alone or combined with targeted therapeutic or cytotoxic chemotherapy administered intravenously).
• Subject accepting to participate in the survey
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 France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2011
Date of last collection (YYYY or MM/YYYY) 2012
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 400
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception
Care consumption (detail) Hospitalization
Medical/paramedical consultation
Medicines consumption
Procedures
Data collection method Inclusion and follow-up questionnaire, and patient self-questionnaire
Participant monitoring Yes
Details on monitoring of participants 9 months during which follow-up data will be collected (status of the patient, professional activity, sick leave, progression of the disease, ECOG score, current posology and changes in dosage of the oral treatment, temporary or definitive stopping of the oral treatment, reasons for stopping and changing dosage, weight, associated treatments, other medical visits, home care, hospitalizations, observance).
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Publications
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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