ITMO public health
Last update : 01/18/2022 | Version : 1 | ID : 74114
| General | |
| Identification | |
| Detailed name | Therapeutic strategies including Avastin as 1st line therapy in elderly patients suffering from advanced (IIIB/IV Stage) non-squamous non-small cell lung cancer, in routine clinical practice |
| Sign or acronym | AVANTAGE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML28621 |
| General Aspects | |
| Medical area |
Cancer research |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Non-squamous non-small cell lung cancer |
| Health determinants |
Medicine |
| Keywords | Bevacizumab |
| Scientific investigator(s) (Contact) | |
| Name of the director | Medical data center |
| 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 carried out as part of an interventional study |
No |
| Database objective | |
| Main objective |
In each cohort of patients defined by their age classification ([65; 70[ and >=70 years), outcome measures are as follows:
- Antineoplastic agents combined with bevacizumab as 1st line therapy - Classes of antineoplastic agents combined with bevacizumab as 1st line therapy (platinum salt, taxanes, ) - Supportive care (growth factors, analgesics). to describe: - Characteristics of advanced nsNSCLC patients treated with bevacizumab as first-line therapy, and their disease characteristics, - Progression-Free Survival (PFS) and Overall Survival (OS), - Evolution of patients’ quality of life over the treatment period with bevacizumab as first-line therapy, - Safety of bevacizumab, - Reasons for non-use of bevacizumab as first-line therapy in patients suffering from advanced nsNSCLC. |
| Inclusion criteria |
Inclusion criteria :
- Patient aged >= 65 years, - Diagnosed with advanced nsNSCLC (stage IIIB or IV), - For whom the physician has decided to initiate a treatment with bevacizumab combined with chemotherapy as 1st line therapy, - Having received oral and written information about the study, and having signed a written consent form. |
| 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) | 2013 |
| Date of last collection (YYYY or MM/YYYY) | 2017 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 277 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Validation of selection criteria ; Information about the study and written consent form ; Demographic and general data ; Disease history ; Bevacizumab treatment ; G8 index and comorbidity index of Charlson, if done ; Response to first-line treatment ; Combined treatments ; First disease progression ; Patient-reported outcomes ; Reason of withdrawal ; Adverse events. |
| Presence of a biobank |
No |
| Procedures | |
| 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 |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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