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