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Tyrosine Kinase Inhibitors In Metastatic Non Small Cell Lung Cancer
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Istituto Clinico Humanitas.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Istituto Clinico Humanitas
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT01163058
First received: June 29, 2010
Last updated: July 27, 2010
Last verified: July 2010
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Purpose
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 |
|---|
| Non Small Cell Lung Cancer |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lung Cancer
U.S. FDA Resources
Further study details as provided by Istituto Clinico Humanitas:
Primary Outcome Measures:
- 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:
- Investigate the association of clinical features such as sex, age, smoking history and histology with oncogenic alterations. [ Time Frame: 1 year ]
| Estimated Enrollment: | 300 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | July 2011 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Non small cell lung cancer patients.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01163058
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163058
Locations
| Italy | |
| Istituto Clinico Humanitas | |
| Rozzano, Milano, Italy, 20059 | |
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
| Principal Investigator: | Armando Santoro, MD | Istituto Clinico Humanitas |
More Information
| Responsible Party: | Armando Santoro, MD, Istituto Clinico Humanitas |
| ClinicalTrials.gov Identifier: | NCT01163058 History of Changes |
| Other Study ID Numbers: |
ONC/OSS-01/2010 |
| Study First Received: | June 29, 2010 |
| Last Updated: | July 27, 2010 |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 23, 2017