TERRA - 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

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Roche Medical Data Center

Last update : 06/30/2022 | Version : 1 | ID : 74128

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
Email 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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