PEPITA - A prospective cohort study assessing the efficacy and safety of Tarceva® in 2nd line in patients with locally advanced or metastatic squamous Non-Small Cell Lung Cancer (NSCLC) – PEPiTA study

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Roche Medical Data Center

Last update : 07/01/2022 | Version : 1 | ID : 74127

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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 A prospective cohort study assessing the efficacy and safety of Tarceva® in 2nd line in patients with locally advanced or metastatic squamous Non-Small Cell Lung Cancer (NSCLC) – PEPiTA study
Sign or acronym PEPITA
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation ML28195
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 Progression Free Survival (PFS) in patients with stage IIIB or IV squamous NSCLC initiating treatment with Tarceva® after failure of first-line platinum-based chemotherapy.

Secondary objectives:
- To describe characteristics of patients treated with Tarceva®;
- To describe Tarceva® treatment modalities in patients with squamous NSCLC after failure of first-line platinum-based chemotherapy;
- To evaluate Overall Survival (OS);
- To describe the evolution of QoL;
- To describe the safety profile of Tarceva®.
Inclusion criteria Inclusion criteria:
1. Adult patients (age >= 18 years);
2. Histologically and/or cytologically confirmed advanced (stage IIIB) or metastatic (stage IV) NSCLC with predominant squamous component (basaloid carcinomas allowed), after failure of first-line platinum-based chemotherapy;
3. For whom the treating physician decided to initiate treatment with Tarceva®;
4. Having received oral and written information about the study and having raised no objections to the collection and analysis of his/her personal data.

Exclusion criteria:
1. Mixed non-small cell and small cell lung carcinoma or mixed squamous cell carcinoma with a predominant adenocarcinoma component;
2. Concomitant participation in a clinical trial evaluating an antineoplastic treatment.
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) 2012
Date of last collection (YYYY or MM/YYYY) 2014
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 152
Data
Database activity Data collection completed
Type of data collected Clinical data
Biological data
Clinical data (detail) Medical registration
Details of collected clinical data Date of visit - Inclusion/eclusion criteria - Demographic data - ECOG - SAP/DAP - Social and occupational data - Risk factors (tobacco use) - Medical history and concomitant diseases - Treatment associated with initiation of Tarceva® - Disease history: primary lung tumor evaluation - Disease history: diagnosis of locally advanced or metastatic disease - EGFR mutation status - First-line treatment of metastatic NSCLC.
Presence of a biobank No
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Quality of life/health perception
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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