Study of Tissue Samples From Patients With Stage I Non-Small Cell Lung Cancer Enrolled on Research Study CALGB-140202

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00990873
First received: October 6, 2009
Last updated: April 24, 2010
Last verified: October 2009
  Purpose

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue samples from patients with stage I non-small cell lung cancer enrolled on research study CALGB-140202.


Condition Intervention
Lung Cancer
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: A Validation of the 64-Gene Signature Using Affymetrix-HG_U133A Array in Stage I NSCLC From the CALGB Lung Cancer Study (140202)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival, defined as the time from surgery to death of any cause [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival, defined as time from surgery to any recurrence (local or regional), second primary tumor, distant metastasis, or death of any cause [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2009
Detailed Description:

OBJECTIVES:

  • Determine whether the 64-gene signature can accurately predict the prognosis for survival of patients with stage I non-small cell lung cancer (NSCLC).

OUTLINE: RNA is purified from tissue samples obtained by the CALGB Lung Cancer Study (CALGB-140202). The RNA samples are used for gene expression analysis using the 64-gene signature and an Affymetrix-HG_U133A array. Reverse-transcriptase PCR may also be performed on selected samples.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of stage I non-small cell lung cancer
  • Enrolled in tissue repository CALGB 140202

PATIENT CHARACTERISTICS:

  • Caucasian race

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990873

Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Ming You, MD Washington University Siteman Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT00990873     History of Changes
Other Study ID Numbers: CDR0000649826, CALGB-150803
Study First Received: October 6, 2009
Last Updated: April 24, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on October 19, 2014