SmokersNCT00483015
Differences in the Presentation Outcome and Response to Treatment Between Never- Smokers and Smokers With NSCLC
An observational study of Smokers, run by Washington University School of Medicine.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Smokers
- What is being tested?
- smoking
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Apr 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age Range 18-88, diagnosed with non- small cell lung cancer between Jan 1 1996 and Dec 31 2002.
Who may be able to join
- Age Range 18-88, diagnosed with non- small cell lung cancer between Jan 1 1996 and Dec 31 2002.
Who cannot join
- Patients diagnosed prior to Dec 31, 1995 and after Jan 1, 2003
About this study
Official title: Differences in the Presentation, Outcome and Response to Treatment Between Never- Smokers and Smokers With Non- Small Cell Lung Cancer.
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
Read the 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].
- Conditions
- Smokers
- Being tested
- smoking
- Keywords
- presentation, outcome, response, never- smokers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smokingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2007 (estimated)
- Study startMar 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SmokersStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramaswamy Govindan, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483015
- Sponsor's protocol ID
- 05-0707
- Status last verified
- Aug 2013
- First submitted
- 4 Jun 2007
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tammemagi CM, Neslund-Dudas C, Simoff M, Kvale P. Impact of comorbidity on lung cancer survival. Int J Cancer. 2003 Mar 1;103(6):792-802. doi: 10.1002/ijc.10882.
PubMed 12516101Sanchez-Cespedes M, Ahrendt SA, Piantadosi S, Rosell R, Monzo M, Wu L, Westra WH, Yang SC, Jen J, Sidransky D. Chromosomal alterations in lung adenocarcinoma from smokers and nonsmokers. Cancer Res. 2001 Feb 15;61(4):1309-13.
PubMed 11245426Vahakangas KH, Bennett WP, Castren K, Welsh JA, Khan MA, Blomeke B, Alavanja MC, Harris CC. p53 and K-ras mutations in lung cancers from former and never-smoking women. Cancer Res. 2001 Jun 1;61(11):4350-6.
PubMed 11389059Gazdar AF. Lung cancer in never smokers - A different pathway. ASCO 2005:619-21
Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8.
PubMed 14974761Nordquist LT, Simon GR, Cantor A, Alberts WM, Bepler G. Improved survival in never-smokers vs current smokers with primary adenocarcinoma of the lung. Chest. 2004 Aug;126(2):347-51. doi: 10.1378/chest.126.2.347.
PubMed 15302716
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in the Presentation, Outcome and Response to Treatment Between Never- Smokers and Smokers With Non- Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00483015
- Acronym / sponsor ID
- 05-0707
- Conditions
- Smokers
- Keywords
- presentation, outcome, response, never- smokers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 6 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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].
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age Range 18-88, diagnosed with non- small cell lung cancer between Jan 1 1996 and Dec 31 2002.
Key inclusion criteria (1 listed)
- Age Range 18-88, diagnosed with non- small cell lung cancer between Jan 1 1996 and Dec 31 2002.
Key exclusion criteria (1 listed)
- Patients diagnosed prior to Dec 31, 1995 and after Jan 1, 2003
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| smoking | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2013.
- Background: PubMed 12516101Tammemagi CM, Neslund-Dudas C, Simoff M, Kvale P. Impact of comorbidity on lung cancer survival. Int J Cancer. 2003 Mar 1;103(6):792-802. doi: 10.1002/ijc.10882.
- Background: PubMed 11245426Sanchez-Cespedes M, Ahrendt SA, Piantadosi S, Rosell R, Monzo M, Wu L, Westra WH, Yang SC, Jen J, Sidransky D. Chromosomal alterations in lung adenocarcinoma from smokers and nonsmokers. Cancer Res. 2001 Feb 15;61(4):1309-13.
- Background: PubMed 11389059Vahakangas KH, Bennett WP, Castren K, Welsh JA, Khan MA, Blomeke B, Alavanja MC, Harris CC. p53 and K-ras mutations in lung cancers from former and never-smoking women. Cancer Res. 2001 Jun 1;61(11):4350-6.
- BackgroundGazdar AF. Lung cancer in never smokers - A different pathway. ASCO 2005:619-21
- Results publication: PubMed 14974761Jemal A, Tiwari RC, Murray T, Ghafoor A, Samuels A, Ward E, Feuer EJ, Thun MJ; American Cancer Society. Cancer statistics, 2004. CA Cancer J Clin. 2004 Jan-Feb;54(1):8-29. doi: 10.3322/canjclin.54.1.8.
- Results publication: PubMed 15302716Nordquist LT, Simon GR, Cantor A, Alberts WM, Bepler G. Improved survival in never-smokers vs current smokers with primary adenocarcinoma of the lung. Chest. 2004 Aug;126(2):347-51. doi: 10.1378/chest.126.2.347.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramaswamy Govindan, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Smokers, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483015, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2013.