ITMO public health
Last update : 11/08/2021 | Version : 1 | ID : 74086
| General | |
| Identification | |
| Detailed name | Non Interventional Study Evaluating Efficacy and Safety in a Cohort of Elderly Patients of First Line Therapy With Avastin ® Regimen for Metastatic Colorectal Cancer |
| Sign or acronym | CASSIOPEE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML27829 |
| General Aspects | |
| Medical area |
Cancer research Gastroenterology et hepatology |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Onco digestive, 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 |
| 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: Progression-free survival in patients aged >= 75 years with metastatic colorectal cancer initiating first line treatment with Avastin®
Secondary Objectives: - To describe the demographic, clinical and nutritional profiles of the patients and their living conditions and degree of autonomy; - To describe the change in autonomy criteria; - To describe the OS; - To describe Avastin® dosage and regimen; - To describe the safety profile of Avastin®. |
| Inclusion criteria |
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). Exclusion criteria: - Patient previously treated with Avastin®. - Patient already participating in a clinical trial evaluating a cytotoxic anticancer therapy and/or an investigational new drug. |
| Population type | |
| Age |
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) | 2012 |
| Date of last collection (YYYY or MM/YYYY) | 2016 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 402 |
| 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 |
| 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 |
| ABOUT | CATALOG | RESOURCES | USEFUL LINKS |
This site complies with the HONcode standard for trustworthy health information: |
8 rue de la Croix Jarry 75013 Paris Phone : +33 1 44 23 67 47 |
Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on December 15 2020 - Version 4.10.05
