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

NCT00990873 | Completed

• 2 other identifiers: CALGB-150803CDR0000649826
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival, defined as the time from surgery to death of any cause

  Up to 5 years

Secondary Outcomes (1)

• Disease-free survival, defined as time from surgery to any recurrence (local or regional), second primary tumor, distant metastasis, or death of any cause

  Up to 5 years

Interventions

gene expression analysis GENETIC

microarray analysis GENETIC

reverse transcriptase-polymerase chain reaction GENETIC

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with stage I non-small cell lung cancer and previously enrolled on CALGB 140202.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Tissues and blood samples

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Gene Expression Profiling; Microarray Analysis; Reverse Transcriptase Polymerase Chain Reaction

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques; Microchip Analytical Procedures; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• Ming You, MD

  Washington University Siteman Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2009
• First Posted: October 7, 2009
• Study Start: July 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 28, 2016

Record last verified: 2016-06