Non-Small Cell Lung Cancer Clinical Trial
— 007/055/OMIOfficial 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
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | June 2012 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Mexico | Instituto Nacional de Cancerología | Mexico | Mexico City |
Lead Sponsor | Collaborator |
---|---|
National Institute of Cancerología | Instituto Nacional de Enfermedades Respiratorias |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | History of smoking and wood smoke exposure | 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. | Exposure factor | No |
Secondary | KRAS and EGFR mutations | 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. | Genotyping | No |
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