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Observational Post-authorization Prospective Study to Characterize the Incidence of Epidermal Growth Factor Receptor (EGFR) Mutation Positive and Advanced Non-small Cell Lung Cancer Patients and Their Clinical Management in Galicia


N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Non-Small-Cell Lung Cancer

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Trial Information

Observational Post-authorization Prospective Study to Characterize the Incidence of Epidermal Growth Factor Receptor (EGFR) Mutation Positive and Advanced Non-small Cell Lung Cancer Patients and Their Clinical Management in Galicia


Inclusion Criteria:



Inclusion Criteria for patients´ screening:

- 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 must fulfill the inclusion criteria previously mentioned and the following one in
order to be enrolled in the study (visit 1) for the follow-up until progression or until 9
months from the beginning of treatment have elapsed:

Inclusion Criteria for patients´ follow-up

- 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of patients with epidermal growth factor receptor (EGFR) positive mutation among advanced or metastatic non-small-cell lung cancer (NSCLC) patients in Galicia

Outcome Time Frame:

10 months (recruitment period)

Safety Issue:

No

Principal Investigator

Sergio Vázquez Estévez, Doctor

Investigator Role:

Study Director

Investigator Affiliation:

Grupo Gallego de Cáncer de Pulmón (GGCP)

Authority:

Spain: Agencia Española de Medicamentos y Productos Sanitarios

Study ID:

GGCP 048-10

NCT ID:

NCT01717105

Start Date:

March 2011

Completion Date:

February 2013

Related Keywords:

  • Metastatic Non-Small-Cell Lung Cancer
  • Non-small cell lung cancer (NSCLC)
  • Epidermal growth factor receptor (EGFR) positive mutation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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