ITMO public health
Last update : 01/18/2022 | Version : 1 | ID : 74115
| General | |
| Identification | |
| Detailed name | A cohort study of patients with advanced, unresectable (stage IIIB) metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC) or in relapse starting treatment with Avastin® in combination with chemotherapy as first line treatment of metastatic disease |
| Sign or acronym | EOLE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML22991 |
| 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 |
This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice
1. To describe characteristics of patients treated with Avastin®: demographic and clinical characteristics, history of the disease, and previous disorders and conditions, 2. To describe methods of use of Avastin® in follow-up: doses and durations of treatment with Avastin® (number of cycles); chemotherapy treatments used in combination with treatment with Avastin®; discontinuation of treatment with Avastin® (temporary and permanent) and reasons; treatment strategies set up after discontinuation of treatment with Avastin®, 3. To describe overall survival of patients treated with Avastin®, 4. To describe the safety profile of treatment with Avastin®: serious and non-serious adverse events and targeted adverse events, 5. To describe quality of life: Spitzer's quality of life questionnaire, 6. To describe therapeutic management of patients with non-squamous cell NSCLC in first-line chemotherapy of metastatic disease not receiving Avastin®: compilation of an anonymous registry over a 3-month period starting with time of scientific set up by the investigator. |
| Inclusion criteria |
Prospective cohort :
- Adult, man or woman patient (age >= 18 years), - With unresectable locally advanced (stage IIIB), metastatic (stage IV) or recurrent non squamous (whenever the histology is not predominantly of squamous cell type) non-small cell lung cancer (NSCLC), and treated in first line setting - Patient starting for the first time a treatment with bevacizumab in first line setting, - Patient having received oral and written information on the study and having no objection to the fact that his (her) personal data will be subjected to data processing. Registry : - Patients with unresectable locally advanced (stage IIIB), metastatic (stage IV) or recurrent non squamous non-small cell lung cancer (NSCLC), and treated in first line setting, - Patients for whom the multidisciplinary committee decided to not initiate a treatment with bevacizumab, - Inclusion in the registry had to be consecutive during the first three months of study participation for each investigator. |
| 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) | 2011 |
| Date of last collection (YYYY or MM/YYYY) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 418 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| 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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