Observational Study to Characterize the Incidence of EGFR Mutation Positive and Advanced NSCLC Patients

NCT ID: NCT01717105

Last Updated: 2012-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-02-28

Brief Summary

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The present study has been designed in order to characterize the incidence of patients with advanced non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) positive mutations and their clinical management in Galicia.

Detailed Description

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Conditions

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Metastatic Non-Small-Cell Lung Cancer

Keywords

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Non-small cell lung cancer (NSCLC) Epidermal growth factor receptor (EGFR) positive mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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metastatic non-small cell lung cancer

Only epidermal growth factor receptor (EGFR) M+ patients will be eligible for the study assessments

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients of both sexes aged 18 or more.
* Histologically confirmed advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) (patients stage III B unsuitable for locoregional treatment, and stage IV).
* Chemo- naïve patients (Non-Small-Cell Lung Cancer patients who have not received first line systemic cytotoxic chemotherapy).
* Patients with available tumoral tissue (primary tumor or metastatic area) or cytological samples including fine needle aspirates (primary tumor or metastatic area), bronchial alveolar lavage or bronchial scrapings and pleural effusion.
* Patients who have granted their written informed consent.



* Patients with documented positive mutation in epidermal growth factor receptor (EGFR) (M+).

Exclusion Criteria

* Combined histology of non-small cell and small cell lung cancer.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Dynamic Solutions

INDUSTRY

Sponsor Role collaborator

Grupo Gallego de Cancer de Pulmon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sergio Vázquez Estévez, Doctor

Role: STUDY_DIRECTOR

Grupo Gallego de Cáncer de Pulmón (GGCP)

Locations

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Centro Oncologico de Galicia

A Coruña, A Coruña, Spain

Site Status

Complexo Hospitalario Arquitecto Marcide

Ferrol, A Coruña, Spain

Site Status

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, A Coruña, Spain

Site Status

Lucus Augusti Hospital

Lugo, Lugo, Spain

Site Status

Complejo Hospitalario de Ourense

Ourense, Orense, Spain

Site Status

Complexo Hospitalario de Pontevedra

Pontevedra, Pontevedra, Spain

Site Status

Hospital do Meixoeiro

Vigo, Pontevedra, Spain

Site Status

Hospital Xeral-Cíes

Vigo, Pontevedra, Spain

Site Status

Hospital Povisa

Vigo, Pontevedra, Spain

Site Status

Countries

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Spain

Other Identifiers

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GGC-CPN-2010-01

Identifier Type: OTHER

Identifier Source: secondary_id

GGCP 048-10

Identifier Type: -

Identifier Source: org_study_id