FRESH-PEF74085-en
Survival in adult patients with BRAF V600 mutation-positive advanced melanoma: a non-interventional ambispective study of a cohort of patients treated with cobimetinib during the French early access program (TAU)
MELANIS
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data']
Individuals
| Topic | Vocabulary |
|---|---|
| Oncology | health theme |
| Dermatology | 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": "Young Adult (19 to 24 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
}
},
{
"value": "Adult (25 to 44 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
}
},
{
"value": "Middle Aged (45 to 64 years)",
"concept": {
"vocab": "MeSH",
"vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008875"
}
},
{
"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: - Patients at least 18 years-old - Patients included in the TAU from 26 February 2015 - Patients with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with Zelboraf® (vemurafenib) - For alive patients: patients who have been informed verbally and in writing about this study who do not object to their data being electronically processed or subjected to data quality control and who have signed the consent form OR - For patients who died before the inclusion period: patients who did not expressed their opposition when they were alive. ",
"clusion_E": "Alive patients unable to give informed consent- patients previously included in cobimetinib clinical trial."
}
| 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 |
|---|---|
| 2016-01-01 | 2018-01-01 |
| 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-PEF74085-en
| Name | Affiliation |
|---|---|
| Camille BACHOT | F. HOFFMANN-LA ROCHE AG |