ITMO public health
Last update : 07/22/2015 | Version : 3 | ID : 2907
| General | |
| Identification | |
| Detailed name | Field Study of innovative therapies in oncology: bevacizumab (Avastin®), an anti-angiogenic agent |
| Sign or acronym | ETNA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTI-RS 06 270, CNIL 906234 |
| General Aspects | |
| Medical area |
Cancer research |
| Health determinants |
Iatrogenic |
| Keywords | Metastatic colorectal cancer, first-line, conditions of use, pharmacoepidemiology, Department of Pharmacology, bevacizumab, Avastin®, tolerance, survival, cohort, 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 |
Mixed |
| Details | National Hospital Clinical Research Program (PHRC) 2005 and additional financial support from Roche SAS (unconditional support) |
| 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 |
An administrative base or a register |
| 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. | Patients treated for the first time by bevacizumab between 1 January 2006 and 31 December 2007 were identified from pharmacy dispensation records of the participating centres. This retrospective identification of patients through pharmacies strengthens the non-interventional aspect, as it does not affect the prescription of the drug. Prescribers in the study were to then inform patients about the collection of their personal data. Patients opposing the collection of data could express this via the physician or by by an instruction included in their medical records, and such patients were not included. |
| Database objective | |
| Main objective | The main objectives of the study were to describe the population of patients with metastatic colorectal cancer and treated in real-life with first-line bevacizumab, describe the conditions of use of this drug, evaluate the safety of treatments and effectiveness in terms of response and overall and progression free survival at 12 and 24 months follow up. |
| Inclusion criteria | Patient with metastatic colorectal cancer who initiated bevacizumab in first-line palliative treatment regardless of the associated cancer treatment between 1 January 2006 and 31 December 2007 (whether or not the treatment is continued); Interval between adjuvant chemotherapy for primary cancer and the initiation of bevacizumab ≥6 months; Absence of chemotherapy for metastases before initiation of bevacizumab; Patient had not previously treated with bevacizumab, including during a clinical trial or Temporary Authorisation of Use; Patient with a prescribing physician or their head of department who agreed to participate in the study; Patient not participating in a clinical trial (Huriet-Sérusclat), unless it has a standard treatment (control arm) in an open-label Phase III study (bevacizumab known); 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 |
National |
| Detail of the geography area | Hospital pharmacists and physicians in metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2007 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 411 |
| 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 event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Data collection method | All medical data required for the study is collected on paper case report forms from medical records by CRAs trained for this study. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | The treatment modalities for eligible patients are collected over 24 months follow-up from the date of the first bevacizumab administration. Vital status is collected at 36 months. Patient characteristics before initiation of treatment and follow-up data are collected from information 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+Etna |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Confidential study reports were submitted to the pharmaceutical company and the Bordeaux University Hospital (study sponsor). Scientific communications (posters, articles, ...) are validated by the study Steering Committee. Ownership of study data was the subject of an agreement between the University of Bordeaux Segalen, the Bordeaux University Hospital and the pharmaceutical company. Terms for third-party access to the database are to be defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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