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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00483015
First received: June 4, 2007
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Smokers
Behavioral: smoking

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Differences in the Presentation, Outcome and Response to Treatment Between Never- Smokers and Smokers With Non- Small Cell Lung Cancer.

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Enrollment: 280
Study Start Date: March 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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].

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00483015

Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Ramaswamy Govindan, M.D. Washington University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00483015     History of Changes
Other Study ID Numbers: 05-0707
Study First Received: June 4, 2007
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
presentation
outcome
response
never- smokers

ClinicalTrials.gov processed this record on April 15, 2014