ETNA - Field Study of innovative therapies in oncology: bevacizumab (Avastin®), an anti-angiogenic agent

Head :
Fourrier-Reglat Annie, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen

Last update : 07/22/2015 | Version : 3 | ID : 2907

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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
Email 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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