NCT00450281|CompletedDMC

S0424 - Carcinogens in Lung Tissue From Smokers (Closed to Entry as of 7/15/07) and Non-Smokers With Newly Diagnosed Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

CDR0000446084S0424U10CA032102

Study Type

observational

Target

981

Locations

1 country

Sites

405

Timeline

RegisteredMar 2007

StartedOct 2005

CompletionJul 2012

Brief Summary

RATIONALE: Studying samples of blood and tissue from smokers (closed to entry as of 7/15/07) and non-smokers with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about risk factors for lung cancer and may help the study of cancer in the future. PURPOSE: This clinical trial is studying carcinogens in lung tissue from smokers (closed to entry as of 7/15/07) and non-smokers with newly diagnosed stage I, stage II, or stage III non-small cell lung cancer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

981

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2005

Longer than P75 for all trials

Geographic Reach

1 country

405 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Start

First participant enrolled

October 1, 2005

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2007

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed

Last Updated

October 26, 2015

Status Verified

December 1, 2013

Enrollment Period

6.8 years

First QC Date

March 20, 2007

Last Update Submit

October 23, 2015

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancerstage IIIA non-small cell lung cancerstage IA non-small cell lung cancerstage IB non-small cell lung cancerstage IIA non-small cell lung cancerstage IIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

DNA adduct levels
End of study
Tumor tissue alterations
End of study

Study Arms (4)

Male, Never-smokers

Male subjects who smoked less than 100 cigarettes during their lifetime.

Genetic: chromogenic in situ hybridizationGenetic: gene expression analysisGenetic: mutation analysisGenetic: polymerase chain reactionGenetic: polymorphism analysisOther: fluorescent antibody techniqueOther: immunohistochemistry staining methodOther: laboratory biomarker analysisOther: matrix-assisted laser desorption/ionization time of flight mass spectrometryOther: study of socioeconomic and demographic variablesProcedure: study of high risk factors

Male, Ever-smokers

Male subjects who have smoked at least 100 cigarettes during their lifetime.

Female, Ever-smokers

Female subjects who have smoked less than 100 cigarettes during their lifetime.