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Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT01163058
Recruitment Status : Unknown
Verified July 2010 by Istituto Clinico Humanitas.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2010
Last Update Posted : July 29, 2010
Sponsor:
Information provided by:
Istituto Clinico Humanitas

Study Description
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Brief Summary:
Aim of the present retrospective study is to evaluate molecular factors of primary resistance to tyrosine kinase inhibitors in metastatic non small cell lung cancer (NSCLC) patients. The investigators assess first, the incidence of epidermal growth factor receptor (EGFR) and Kirsten ras sarcoma viral oncogene homolog (KRAS) mutations, SOS and hepatocyte growth factor (HGF) expression, anaplastic lymphoma kinase (ALK) translocation and expression and, secondly, the investigators correlate molecular markers with clinical features and outcome in terms of response rate, progression free survival and overall survival.

Condition or disease
Non Small Cell Lung Cancer

Detailed Description:
Non small cell lung cancer patients.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis Evaluating Molecular Factors of Primary Resistance to Tyrosine Kinase Inhibitors in Metastatic Non Small Cell Lung Cancer Patients
Study Start Date : June 2010
Actual Primary Completion Date : July 2010
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Determine the incidence of EGFR (Epidermal growth factor ) and KRAS (Kirsten ras sarcoma viral oncogene homolog ) mutations in 300 NSCLC (non small cell lung cancer) patients treated with gefitinib or erlotinib [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations. [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
non small cell lung cancer patients treated with gefitinib or erlotinib
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of NSCLC (non small cell lung cancer) with available tumor tissue for mutational analysis
  • Metastatic disease treated with gefitinib or erlotinib
  • Presence of at least one measurable lesion according to RECIST criteria

Exclusion Criteria:

  • No tumor tissue available
  • No clinical data available
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163058


Locations
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Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20059
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
More Information
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Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT01163058     History of Changes
Other Study ID Numbers: ONC/OSS-01/2010
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: July 29, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms