FRESH-PEF74086-en
Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer
CASSIOPEE
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data']
Individuals
| Topic | Vocabulary |
|---|---|
| Oncology | health theme |
| Gastroenterology | 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": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
}
},
{
"value": "Female",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
}
}
],
"level_age_clusion_I": [
{
"value": "Aged (65 to 79 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000368"
}
},
{
"value": "Aged, 80 and over (80 years and more)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000369"
}
}
],
"level_type_clusion_I": [
"Patients population"
],
"level_type_clusion_other": "",
"clusion_I": "Inclusion criteria: - Adult patient aged >= 75 years, - With metastatic adenocarcinoma of the colon or rectum, - For whom it has been decided to initiate first line treatment with Avastin®, concomitant to or no more than 2 months after the start of first line chemotherapy - Having received oral and written information about the study objectives and methods and having raised no objections to computer processing of the data in the medical record (indirectly named data). ",
"clusion_E": "Patient previously treated with Avastin®. - Patient already participating in a clinical trial evaluating a cytotoxic anticancer therapy and\/or an investigational new drug."
}
| Name | Role |
|---|---|
| F. HOFFMANN-LA ROCHE AG | sponsor |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2012-01-01 | 2016-01-01 |
| Standard |
|---|
| ['CDISC like'] |
['GCP/GVP']
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
| Name | |
|---|---|
| ;Medical data center | data_sharing.france@roche.com |
FRESH-PEF74086-en
| Name | Affiliation |
|---|---|
| Camille BACHOT | F. HOFFMANN-LA ROCHE AG |