BREAST CANCER CHEMOTHERAPY - Prospective Cohort of Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer
Head :
Ghiringelli François, INSERM CRI 866 EPIDEMIOLOGIE CANCER ET NUTRITION FACULTE DE MEDECINE
Coudert , ONCOLOGIE MEDICALE
Coudert , ONCOLOGIE MEDICALE
Last update : 06/29/2014 | Version : 1 | ID : 60092
| General | |
| Identification | |
| Detailed name | Prospective Cohort of Patients Receiving Neoadjuvant Chemotherapy for Breast Cancer |
| Sign or acronym | BREAST CANCER CHEMOTHERAPY |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Date de réception de l'avis favorable de la CNIL : 05/02/2002 |
| General Aspects | |
| Medical area |
Cancer research |
| Others (details) | Breast cancer |
| Keywords | state, local recurrence, metastatic, histological data, imaging, Health episodes, death, treatment, classification, surgery |
| Scientific investigator(s) (Contact) | |
| Name of the director | Ghiringelli |
| Surname | François |
| fghiringhelli@dijon.fnclcc.fr | |
| Unit | INSERM CRI 866 EPIDEMIOLOGIE CANCER ET NUTRITION FACULTE DE MEDECINE |
| Organization | CHU |
| Name of the director | Coudert |
| Address | 21079 DIJON |
| bcoudert@dijon.fnclcc.fr | |
| Unit | ONCOLOGIE MEDICALE |
| Organization | CENTRE GEORGES FRANÇOIS |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | CENTRE GEORGES FRANCOIS LECLERC |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | SERIVCE D'ONCOLOGIE ET UNITE DE BIOSTATISTIQUE, CHU DIJON |
| 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 carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Inclusion method: Prospective |
| Database objective | |
| Main objective | General objective: To evaluate the medical, clinical, biological and therapeutic characteristics of breast cancer patients receiving neoadjuvant chemotherapy Secondary objectives: - To evaluate the long-term impact of therapeutic schemas on recurrence-free overall survival; - To validate the current prognostic scores from a U.S. population on an independent French cohort; - To identify prognostic variables and select those relevant to the establishment and evaluation of a new score from our database to reflect new biological data (Chevallier and Sataloff scores and molecular classification); - To compare the prognostic qualities of the new score to the U.S. score; - To conduct an external validation of these scores (through collaboration with the Institut Gustave Roussy team in Villejuif and the Institute Bergonie team in Bordeaux); - To isolate genetic (constitutional), genomic (tumour) or immunohistological factors with predictive power for treatment response and prognosis. |
| Inclusion criteria | - Patients with breast cancer receiving neoadjuvant chemotherapy; - patient's written consent. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Woman |
| Geography area |
Regional |
| French regions covered by the database |
Bourgogne Franche-Comté |
| Detail of the geography area | Burgundy |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1990 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 465 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Paraclinical data Biological data |
| Paraclinical data (detail) | Imaging |
| Biological data (detail) | Type of samples taken: Initial biopsy and surgical specimen (frozen or paraffin conservation) serum |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum DNA |
| Details of biobank content | Serum bank, DNA bank |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Clinical examinations: Direct input Biological analysis: Direct input |
| Participant monitoring |
Yes |
| Details on monitoring of participants | (Indeterminate duration) |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | PMSI, Pathology registry |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/21750556 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/21437909 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/20229175 |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/18413832 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Access for biological portion of study carried out in INSERM Unit U866 (Prof. Eric Solary, Dr. Ghiringhelli) in Dijon and INSERM Unit 645 in Besançon Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
