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

NCT ID: NCT00990873

Last Updated: 2016-06-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-11-30

Brief Summary

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.

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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

gene expression analysis

Intervention Type: GENETIC

microarray analysis

Intervention Type: GENETIC

reverse transcriptase-polymerase chain reaction

Intervention Type: GENETIC

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Registration to CALGB 140202

2. Institutional Review Board (IRB) review and approval at the institutions where the laboratory work will be performed is required

3. Informed Consent: The CALGB does not require that a separate consent form be signed for this study

• The subject population to be studied in this protocol includes patients selected from CALGB 140202. All such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial.
• All samples to be studied were obtained and stored as part of CALGB 140202. The material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information. In no instance will the patient be contacted directly.
• There should be no physical, psychological, social or legal risks associated with this study. No invasive procedures are recommended or requested.
• All appropriate and necessary procedures will be utilized to maintain confidentiality. All patients who have had samples submitted for analysis will have their CALGB study number used to identify specimens.
• This study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated. It is likely however, that the information gained will substantially help similar patients in the future.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ming You, MD

Role: STUDY_CHAIR

Washington University Siteman Cancer Center

Other Identifiers

CALGB-150803

Identifier Type: -

Identifier Source: secondary_id

CDR0000649826

Identifier Type: REGISTRY

Identifier Source: secondary_id

CALGB-150803

Identifier Type: -

Identifier Source: org_study_id