ITMO public health
Last update : 01/31/2012 | Version : 1 | ID : 3082
| General | |
| Identification | |
| Detailed name | Chronic toxicities in patients with early breast cancer |
| Sign or acronym | CANTO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | N° CPP : 11.039 N° AFSSAPS : B111158-20 |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Genetic Iatrogenic |
| Others (details) | breast cancer |
| Keywords | adversed effects, long term toxicity, financial impact, predictors for chronic toxicity, toxicity, psychological impact, social impact, biomarkers |
| Scientific investigator(s) (Contact) | |
| Name of the director | Andre |
| Surname | Fabrice |
| Address | 114 rue Edouard Vaillant 94805 Villejuif |
| fabrice.andre@inserm.fr | |
| Unit | Inserm U981 |
| Organization | Institut Gustave Roussy |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | ANR "Investissements d'avenir -Grand emprunt", Biomérieux, INCA, |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut Gustave Roussy (IGR) |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | Fédération Nationale des centres de lutte contre le Cancer |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| 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 |
| Database objective | |
| Main objective |
The primary goal will be to generate predictors of chronic toxicity in patients with early brest cancer treated with anticancer agents. This project will include four specific aims: - To develop a database of chronic toxicity in a cohort of 20 000 women with stage I-III breast cancer - To describe incidence, clinical presentation, biological characteristics and outcome of chronic toxicities - To describe the psychosocial and economic impact of chronic toxicities - To generates predictors for chronic toxicities |
| Inclusion criteria | Women with non-metastasic breast cancer (I to III stade) treated in one of the 10 medical centers involved in the study |
| Population type | |
| Age |
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 territory |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2012 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | 20 000 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Heart US, MRI joint, electromyogram, bone densitometry, Uterine US |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood |
| Details of biobank content | whole blood |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Data collection method | Inclusion: each women will fil a first questionaire for demographics and living conditions, and a set of validated questionnaries related to QoL (BR 23) and special psychological dimensions. MDs will fill the questionnaire |
| 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) | Ask the person in charge |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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