ITMO public health
Last update : 01/01/2018 | Version : 3 | ID : 2912
| General | |
| Identification | |
| Detailed name | Assessment of chemotherapy practices in patients with colorectal cancer at the Bordeaux University Hospital |
| Sign or acronym | COLCHIC |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTI-RS 06.220, CNIL 906212 |
| General Aspects | |
| Medical area |
Cancer research |
| Keywords | Colorectal cancer, evaluation of professional practice, chemotherapy, recommendations, targeted therapy, pharmacoepidemiology, cohort, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | Fourrier-Reglat |
| Surname | Annie |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| annie.fourrier@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Name of the director | Moore |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue Léo Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@pharmaco.u-bordeaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | Financement sur fonds propres - Self-financed |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisation status |
Public |
| 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 |
| Additional information regarding sample selection. | The patients treated at the Bordeaux University Hospital for colorectal cancer between 1 March 2005 and 1 March 2006 were identified from the PMSI (Programme de Médicalisation des Systèmes d'Information) managed by the Department of Medical Information of the Bordeaux University Hospital. The inclusion criteria were then manually checked by CRAs using medical records. |
| Database objective | |
| Main objective | The main objective was to evaluate the conditions of use and monitoring of chemotherapy for the treatment of colorectal cancer clinical departments at the University Hospital of Bordeaux, and to assess the appropriateness of prescribing practices in relation to current official recommendations. |
| Inclusion criteria | Patient with colon or rectal cancer treated with chemotherapy between 1 March 2005 and 1 March 2006; Patient followed at the Bordeaux University Hospital; Patient not objecting to the data collection. |
| 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 |
Male Woman |
| Geography area |
Local |
| French regions covered by the database |
Aquitaine Limousin Poitou-Charentes |
| Detail of the geography area | Bordeaux University Hospital |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2007 |
| Date of last collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 204 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Data collection method | All the medical data required for the study was collected on paper case report forms from medical records by CRAs trained for this study. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | For each patient, the date of inclusion was the first day of chemotherapy cycle identified between 1 March 2005 and 1 March 2006. This date corresponded to the start of 18-month follow-up. This follow-up was performed using data available in medical records. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=%28Fourrier-Reglat+A[author]+OR+Moore+N[author]%29+AND+colchic |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | For each patient, the date of inclusion was the first day of chemotherapy cycle identified between 1 March 2005 and 1 March 2006. This date corresponded to the start of 18-month follow-up. This follow-up was performed using data available in medical records. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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