Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00483015
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2007-06-04
Brief Title:
Differences in the Presentation Outcome and Response to Treatment Between Never- Smokers and Smokers With NSCLC
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Differences in the Presentation Outcome and Response to Treatment Between Never- Smokers and Smokers With Non- Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We wish to discover if there is a difference in the presentation response to treatment and survival of never- smokers with lung cancer as compared to ever- smokers
We also plan to obtain tumor specimens to compare the genetic and proteomic expression between smokers and never smokers
We also plan to obtain tumor specimens to compare the genetic and proteomic expression between smokers and never smokers
Detailed Description:
Lung cancer is the most lethal of all malignant tumors affecting humans In the United States alone an estimated 160440 patients died of lung cancer 20041 It is well known that tobacco smoking is a major risk factor and accounts for the majority of all lung cancer cases But there is a sub group of patients with lung cancer who have never actively smoked tobacco This group exhibits certain unique characteristics which separates them from lung cancer in smokers It has been shown that never- smokers with adenocarcinoma have better outcomes in terms of overall survival as well as lung cancer specific survival when compared to current smokers with adenocarcinoma of the lung2 Also patients who are current smokers at diagnosis have decreased survival when compared to people who quit smoking3 The improved survival in never smokers could be due to several reasons Such as increased incidence of co-morbid factors in smokers as result of exposure to tobacco smoke differences in metabolism of chemotherapeutic agents or a reflection of differences in the underlying molecular biology of the tumor
It has been demonstrated that chromosomal abnormalities are common in lung cancer patients with a smoking history when compared to never- smokers4 Gene mutations such as p53 mutations are more frequent in never- smokers than in previous smokers5 In addition mutations that are specific only to lung cancer in never smokers have been discovered demonstrating the possibility of a separate or overlapping carcinogenesis pathway for lung cancer in never smokers vs smokers 6
It has been demonstrated that chromosomal abnormalities are common in lung cancer patients with a smoking history when compared to never- smokers4 Gene mutations such as p53 mutations are more frequent in never- smokers than in previous smokers5 In addition mutations that are specific only to lung cancer in never smokers have been discovered demonstrating the possibility of a separate or overlapping carcinogenesis pathway for lung cancer in never smokers vs smokers 6
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None