ITMO public health
Last update : 06/30/2022 | Version : 1 | ID : 74128
| General | |
| Identification | |
| Detailed name | Study of a patient cohort with locally advanced or metastatic non-small cell lung cancer treated with Tarceva® (Erlotinib) monotherapy and without progression after at least nine months |
| Sign or acronym | TERRA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | ML22973 |
| General Aspects | |
| Medical area |
Cancer research |
| Study in connection with Covid-19 |
No |
| Pathology (details) | Non-Small Cell Lung Cancer (NSCLC) |
| Health determinants |
Iatrogenic Medicine |
| Keywords | ERLOTINIB |
| Scientific investigator(s) (Contact) | |
| Name of the director | Roche Medical Data Center |
| Address | 4 cours de l'Ile Seguin - 92650 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 | |
| Name of the contact | https://www.roche.fr/fr/innovation-recherche-medicale/data-sharing-portail-d-information-partage-des-donnees.html |
| 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: To describe the progression-free survival of a population of patients with metastatic or locally advanced NSCLC treated with Tarceva® monotherapy whose disease has not progressed for at least nine months.
Secondary objectives: - To describe patients’ characteristics at inclusion in the study and on initiation of treatment with Tarceva® monotherapy (demographic, clinical, and biological characteristics); - To describe the use of Tarceva®; - To evaluate the efficacy of treatment with Tarceva®: the best response obtained (complete response, partial response, or stabilisation), overall survival, and prognostic criteria for long-term survival on Tarceva®; - To describe the long-term safety profile of Tarceva®; - To describe the correlations between tumour biology and response to Tarceva®; - To describe patient adherence to Tarceva® monotherapy using the Morisky scale; - To describe the change in quality of life for patients treated with Tarceva® monotherapy, using the FACT-L questionnaire. |
| Inclusion criteria |
Inclusion criteria:
- Adult patients (age >= 18 years); - Treated with Tarceva® monotherapy for a locally advanced or metastatic NSCLC (stage IIIB/IV) and without disease progression for at least nine months; - Agreed to be monitored for the whole duration of the observation (24 months maximum); - Who received both oral and written information about the study without objection to their data being subject to automated processing. Exclusion criteria: - None. |
| 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 | D02 - Carcinoma in situ of middle ear and respiratory system |
| 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) | 2013 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 217 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Details of collected clinical data | Validation of selection criteria - Information about the study - Demographic and general data - NSCLC history - Biomarkers if available - Performance status (ECOG) - Tarceva® therapy - Combined treatments - Anticancer treatments after Tarceva® permanent discontinuation - Disease progression - Adverse events under Tarceva® therapy, over the retrospective study period - Adverse events over the prospective study period - Reason for early study withdrawal. |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Medicines consumption |
| Procedures | |
| Data collection method | eCRF |
| Classifications used | CDISC |
| 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 |
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