FRESH-PEF2907-en
Field Study of innovative therapies in oncology: bevacizumab (Avastin®), an anti-angiogenic agent
ETNA
| Name | Country code |
|---|---|
| France | fr |
['Clinical data']
Individuals
| Topic | Vocabulary |
|---|---|
| Oncology | health theme |
| Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic, central nervous system or related tissues | cim-11 |
| Healthcare system determinants: Use of care | health determinant |
| Healthcare system determinants | health determinant |
{"level_sex_clusion_I":[{"value":"Male","concept":{"vocab":"MeSH","vocabURI":"D008297"}},{"value":"Female","concept":{"vocab":"MeSH","vocabURI":"D005260"}}],"level_age_clusion_I":[{"value":"Young Adult (19 to 24 years)","concept":{"vocab":"MeSH","vocabURI":"D055815"}},{"value":"Adult (25 to 44 years)","concept":{"vocab":"MeSH","vocabURI":"D000328"}},{"value":"Middle Aged (45 to 64 years)","concept":{"vocab":"MeSH","vocabURI":"D008875"}},{"value":"Aged (65 to 79 years)","concept":{"vocab":"MeSH","vocabURI":"D000368"}},{"value":"Aged, 80 and over (80 years and more)","concept":{"vocab":"MeSH","vocabURI":"D000369"}}],"level_type_clusion_I":"Patients population","level_type_clusion_other":"","clusion_I":"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.","clusion_E":""}
| Name |
|---|
| Annie;FOURRIER-REGLAT |
| Nicholas;MOORE |
| Name | Role |
|---|---|
| UNIVERSITE DE BORDEAUX | sponsor |
| Name |
|---|
| F. HOFFMANN-LA ROCHE AG |
| MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES |
| Agency name |
|---|
| CNIL |
['Medical-administrative database (patients, health insurance/mutual insurance)','Disease and death registry']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2007-01-01 | 2011-01-01 |
Ownership of study data was the subject of an agreement between the University of Bordeaux Segalen, the Bordeaux University Hospital and the pharmaceutical company.
{"value":"To be defined","extLink":[]}
| Name | |
|---|---|
| Annie;FOURRIER-REGLAT | annie.fourrier-reglat@u-bordeaux.fr |
| Nicholas;MOORE | nicholas.moore@u-bordeaux.fr |