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NCT01525199 Clinical Trial

Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

Non-Small Cell Lung Cancer Clinical Trial

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Official title:
Study of Cases and Controls on Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01525199
Other study ID # NIS-OAR-XXX-2011/1
Secondary ID
Status Completed
Phase N/A
First received January 31, 2012
Last updated April 11, 2014
Start date May 2012
Est. completion date November 2013

Study information
Verified date April 2014
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Study type Observational

Clinical Trial Summary

The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.

Description:

Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV.

- Patients under 1st line treatment against lung adenocarcinoma.

Exclusion Criteria:

- Patients not having the information required by the protocol.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Argentina Research Site Bahia Blanca Buenos Aires
Argentina Research Site Bolivar Buenos Aires
Argentina Research Site Ciudad de Buenos Aires Buenos Aires
Argentina Research Site Cordoba
Argentina Research Site Gral. Roca Rio Negro
Argentina Research Site Junin Buenos Aires
Argentina Research Site La Plata Buenos Aires
Argentina Research Site La Rioja
Argentina Research Site Lanus Buenos Aires
Argentina Research Site Lomas de Zamora Buenos Aires
Argentina Research Site Mar del Plata Buenos Aires
Argentina Research Site Mendoza
Argentina Research Site Rosario Santa Fe
Argentina Research Site San Luis
Argentina Research Site Santa Fe
Argentina Research Site Santa Rosa La Pampa
Argentina Research Site Tucuman

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Argentina, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease free survival 12 months after the diagnosis of advanced disease No
Primary Overall Survival 12 months after the diagnosis of advanced disease No
Primary Number of hospitalizations 12 months after the diagnosis of advanced disease No
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