MELANIS - 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)

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Roche Medical data center

Last update : 11/08/2021 | Version : 1 | ID : 74085

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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 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)
Sign or acronym MELANIS
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ML29964
General Aspects
Medical area Cancer research
Dermatology, venereology
Study in connection with Covid-19 No
Pathology (details) Onco dermatology, BRAF V600 melanoma
Health determinants Medicine
Keywords cobimetinib
Scientific investigator(s) (Contact)
Name of the director Roche Medical data center
Address 4 cours de l'Ile Seguin - 92100 Boulogne-Billancourt
Email data_sharing.france@roche.com
Organization Roche SAS
Collaborations
Participation in projects, networks and consortia No
Funding
Funding status Private
Governance of the database
Sponsor(s) or organisation(s) responsible Roche SAS
Organisation status Private
Presence of scientific or steering committees Yes
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Database objective
Main objective Primary Objective: To estimate the OS of patients treated with cobimetinib in combination with vemurafenib
Secondary Objectives:
- To assess the PFS
- To identify prognostic factors of OS
- To identify prognostic factors of PFS
- To describe response to treatment (overall assessment of the physician)
- To describe time to treatment discontinuation.
- To characterize the targeted AE of cobimetinib in combination with vemurafenib under real-world conditions of useTo describe the long term safety profile of cobimetinib in association with vemurafenib under real-world conditions of use
Exploratory Objectives:
- To describe population of patients treated with cobimetinib in combination with vemurafenib
- To describe the use of cobimetinib in combination with vemurafenib
Inclusion criteria 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.
Exclusion criteria:
- Alive patients unable to give informed consent
- Patients previously included in cobimetinib clinical trial.
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
Pathology C00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
Gender Male
Woman
Geography area National
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2016
Date of last collection (YYYY or MM/YYYY) 2018
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 198
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Medical registration
Details of collected clinical data Type of data collected : informed consent, inclusion/exclusion criteria, date of the visit, demographic data, clinical data, medical history, disease history and prior melanoma therapies, treatment with cobimetinib, concomitant medications for melanoma (including vemurafenib), first disease progression, evaluation of lesions (as assessed by the physician), vital status, targeted adverse events (before inclusion), adverse events (after inclusion), early study termination.
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Procedures
Data collection method eCRF
Classifications used CDISC like
Quality procedure(s) used GCP/GVP
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the referring doctor
Followed pathology C00-C75 - Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
Links to administrative sources No
Promotion and access
Promotion
Access
Dedicated website https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html
Presence of document that lists variables and coding procedures Yes
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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