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Trial record 10 of 87 for:    lung cancer AND risk factors

K-RAS Oncogene Mutation in Patients With Advanced Non-Small Cell Lung Cancer Associated With Exposure to Wood Smoke and Tobacco Smoking: Therapeutic Implications (007/055/OMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023828
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : June 29, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Summary:

Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related death in the world. This neoplasia has a poor survival prognosis due to the low effectiveness of existing treatments. The low effectiveness is associated with the development of an intrinsic and acquired resistance of tumors, which clinically shows through early progression and transitory responses. Tobacco smoking is the major risk factor for NSCLC; however, wood smoke has been described as a strong carcinogen and a relevant risk factor for the development of NSCLC. Current data indicates that lung tumors associated with tobacco smoking and wood smoke show different clinical characteristics, which suggests that they might also have different genetic alterations, which are a consequence of tumor etiology. The description of the frequency and the type of mutations associated with different etiologies of NSCLC could represent the starting point for benefiting each patient according to their specific characteristics. One of the most researched signaling pathways related to cancer cell proliferation is the one activated by the K-RAS oncogene. Active K-RAS mutations have been detected in different types of neoplasia and more than 90% of these mutations occur at codon 12 of the oncogene. These mutations seem to be an independent risk factor for the prognosis of malignant tumors and they are associated with the lack of response to erlotinib, which is a tyrosine-kinase inhibitor. The investigators' research team has recently reported that wood smoke is an independent factor for survival and response to the erlotinib treatment, which suggests that this carcinogen could have a different frequency and pattern of mutations in the K-RAS oncogene, compared to what has been reported in smoking patients. Determining the tumor mutations within the K-RAS oncogene can help improve the response prognosis of patients with advanced NSCLC who have a background of exposure to different factors associated with the appearance of this neoplasia, such as wood smoke exposure or tobacco smoking. Therefore, the objective of this research is to determine the frequency and the type of mutations at codon 12 of the K-RAS oncogene in patients with NSCLC who have a background of exposure to tobacco smoking or wood smoke.


Condition or disease
Non-Small Cell Lung Cancer

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Study Design

Study Type : Observational
Actual Enrollment : 150 participants
Time Perspective: Retrospective
Official Title: K-RAS Oncogene Mutation in Patients With Advanced Non-Small Cell Lung Cancer Associated With Exposure to Wood Smoke and Tobacco Smoking: Therapeutic Implications
Study Start Date : April 2005
Primary Completion Date : January 2010
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer Smoking
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
TOBACCO SMOKING
Group of patients with diagnosis of NSCLC and exposure to tabacco smoking
WOOD SMOKE
Patients whit diagnosis of NSCLC and exposure to wood smoke
TABACCO SMOKING AND WOOD SMOKE
Patients whit diagnosis of NSCLC and exposure to tabacco smoking and wood smoke
WHITOUT EXPOSURE
Patients whit diagnosis of NSCLC and whitout exposure to risk factor


Outcome Measures

Primary Outcome Measures :
  1. History of smoking and wood smoke exposure [ Time Frame: Exposure factor ]
    Tumor specimens were collected at the time of diagnosis. WSE was defined as being exposed to fumes resulting from burning wood in fireplaces and wood stoves for >5 years for at least 4 hours per day. The WSE index was calculated by multiplying the number of daily hours exposed by the number of years' exposure. A non-smoker was defined as being someone having a lifetime exposure of less than 100 cigarettes; the tobacco smoking index was calculated by multiplying the number of cigarette packs consumed per day by the number of years spent smoking.


Secondary Outcome Measures :
  1. KRAS and EGFR mutations [ Time Frame: Genotyping ]
    EGFR (exon 18-21) and KRAS gene mutations from some samples were detected by Therascreen RGQ PCR Kit (QUIAGEN, Scorpions ARMS method), according to the manufacturer's instructions from the four arms.


Biospecimen Retention:   Samples With DNA
The tumor samples, both formalin-fixed or paraffin-embedded, used for the histological diagnosis of patients will be obtained from the Pathology Departments of the National Cancer Institute and the National Institute of Respiratory Diseases; these samples will be used to gather DNA for the analysis of K-RAS mutations. The clinical data of the patients will be obtained from their medical files.

Eligibility Criteria

Information from the National Library of Medicine

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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
For the purpose of this research, the presence of mutations at the K-RAS oncogene were evaluated retrospectively in 50 patients with advanced NSCLC who have a background of wood smoke exposure and 50 patients with NSCLC who have a background of tobacco smoking. Additionally, 50 patients with NSCLC with or without a background of exposure to any of these risk factors for lung cancer will be prospectively evaluated.
Criteria

Inclusion Criteria:

  • Patients diagnosed with advanced NSCLC stage IIIB/IV who have not received previous chemotherapy
  • Radiotherapy or both and who have tumor tissue embedded in paraffin blocks or formalin-fixed
  • These patients must sign an informed consent letter.

Exclusion Criteria:

  • Patients who refuse to participate in the study or those who decide to withdraw from it.
  • Patients without tumor tissue or with a poor quality sample.
Contacts and Locations

Information from the National Library of Medicine

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): NCT01023828


Locations
Mexico
Instituto Nacional de Cancerología
Mexico, Mexico City, Mexico, 14080
Sponsors and Collaborators
National Institute of Cancerología
Instituto Nacional de Enfermedades Respiratorias
Investigators
Principal Investigator: Oscar Arrieta, MD; MsC Instituto Nacional de Cancerología
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: DR. MYRNA CANDELARIA, MD, National Institute of Cancerología
ClinicalTrials.gov Identifier: NCT01023828     History of Changes
Other Study ID Numbers: INCAN/CC/394/07
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012

Keywords provided by DR. MYRNA CANDELARIA, National Institute of Cancerología:
K-RAS ONCOGENE MUTATION
NON-SMALL CELL LUNG CANCER
WOOD SMOKE

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