ITMO public health
Last update : 06/23/2015 | Version : 2 | ID : 212
| General | |
| Identification | |
| Detailed name | Suivi de cohorte de patientes opérées d'un cancer du sein infiltrant, unifocal, de taille histologique inférieure ou égale à 10 mm et sans envahissement ganglionnaire |
| Sign or acronym | Odissee |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°908500 |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Iatrogenic |
| Scientific investigator(s) (Contact) | |
| Name of the director | Benkanoun |
| Surname | Chahinez |
| Address |
30 Cours de l'Iles Seguin 92650 BOULOGNE-Billancourt Cedex France |
| Phone | +33 (0)1 47 61 47 08 |
| chahinez.benkanoun@roche.com | |
| Organization | Laboratoire Roche |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Roche Laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Laboratoire ROCHE |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is is made on the basis of: |
Another treatment or procedure |
| Database recruitment is carried out as part of an interventional study |
No |
| Database objective | |
| Main objective | Describe the management of patients with invasive, unifocal, pT1a or b , N0, M0 breast cancer (histological size less than or equal to 10mm) |
| Inclusion criteria |
- Adult patients (at least 18 years of age)
- Diagnostic of invasive, unifocal breast cancer of small histological size (pT1a or b, pN0 , Mo or Mx) - Surgical excision performed after 01/04/2009 - Patient follow up planned by the physician - Patients who have been informed of the study orally and in writing |
| 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 | National |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2021 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 650 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
Yes |
| Contents of biobank |
Tissues |
| Details of biobank content | paraffin-embedded tumor blocks |
| Health parameters studied |
Health event/mortality |
| Procedures | |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
The presentations and publications relative to the study are in progress.
First results have been presented during french and european congresses To date, it is not planned for a research team to have access to the data from the study |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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