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OpenTrials
Completed

NCT Number: NCT00483015

Differences in the Presentation Outcome and Response to Treatment Between Never- Smokers and Smokers With NSCLC

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

Completed

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Key information

Conditions

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Observational

About this study

Lung cancer is the most lethal of all malignant tumors affecting humans. In the United States alone an estimated 160,440 patients died of lung cancer 2004[1]. 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 lung[2]. Also patients who are current smokers at diagnosis have decreased survival when compared to people who quit smoking[3]. 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- smokers[4]. Gene mutations such as p53 mutations are more frequent in never- smokers than in previous smokers[5]. 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].

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age Range 18-88, diagnosed with non- small cell lung cancer between Jan 1 1996 and Dec 31 2002.

Exclusion criteria

  • Patients diagnosed prior to Dec 31, 1995 and after Jan 1, 2003

Treatment and study plan

smoking

Behavioral

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Differences in the Presentation, Outcome and Response to Treatment Between Never- Smokers and Smokers With Non- Small Cell Lung Cancer.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 6, 2007
Registry last updated
Aug 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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