PICASSO - A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable

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Roche Medical data center

Last update : 11/08/2021 | Version : 1 | ID : 74087

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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 A Cohort Study of Patients With Metastatic Colorectal Cancer Treated With Avastin® as First-line Therapy for Liver Metastases Considered as Potentially Resectable
Sign or acronym PICASSO
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ML22999
General Aspects
Medical area Gastroenterology et hepatology
Study in connection with Covid-19 No
Pathology (details) Metastatic colorectal cancer
Health determinants Medicine
Keywords bevacizumab
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 care professionals
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: evaluate the efficacy and safety of bevacizumab as first-line treatment in participants with colorectal cancer and potentially resectable liver metastases.
Secondary Objectives:
- To describe patients’ characteristics treated with Avastin®,
- To describe the subgroup of patients with unresected missing metastases, with or without surgery,
- To describe criteria used to define unresectability,
- To describe progression-free survival in all patients,
- To describe relapse-free survival in all resected patients with no DMD,
- To describe overall survival in all patients,
- To describe histopathological response in resected patients,
- To describe Avastin® treatment modalities,
- To describe safety profile of Avastin®.
Inclusion criteria Inclusion criteria:
- Man or woman aged 18 years or over,
- Diagnosed with a colon or rectal adenocarcinoma including exclusively liver or liver and lung metastases,
- For whom a first-line treatment with Avastin® was set up by a MDC in the context of potentially resectable metastatic disease,
- Who has been informed orally and in writing about the study, its objectives and modalities of implementation and who did not object that the collected data were subject to an automated processing.
Exclusion criteria:
- Patient considered as upfront resectable at inclusion,
- Patient considered as he/she could never be resectable,
- Patient already enrolled in a clinical study for cytotoxic anticancer medication and/or innovative therapy.
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) 2010
Date of last collection (YYYY or MM/YYYY) 2015
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 218
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Clinical data (detail) Medical registration
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
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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