Cancer Genome Study Using Samples From Patients With Stage I or Stage II Non-Small Cell Lung Cancer Treated on Clinical Trial ACOSOG-Z0030

NCT00899535 | Completed

• 2 other identifiers: ACOSOG-Z4082CDR0000617514
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030.

Conditions

Lung Cancer

Keywords

adenocarcinoma of the lung; large cell lung cancer; squamous cell lung cancer; stage I non-small cell lung cancer; stage II non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Clinical relevance of conducting comprehensive molecular analyses on clinically annotated high-quality tumor biospecimens

  Up to 3 years

Study Arms (1)

Group 1

This research study is looking at the cancer genome using tumor samples from patients with stage I or stage II non-small cell lung cancer treated on clinical trial ACOSOG-Z0030. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

Genetic: DNA analysis; Genetic: RNA analysis; Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis

Interventions

DNA analysis GENETIC

Group 1

RNA analysis GENETIC

Group 1

microarray analysis GENETIC

Group 1

mutation analysis GENETIC

Group 1

polymorphism analysis GENETIC

Group 1

Eligibility Criteria

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

Study Population

Patients diagnosed with non-small cell carcinoma previously registered on ACOSOG-Z0030.

DISEASE CHARACTERISTICS: * Diagnosis of non-small cell carcinoma * Primary, untreated disease * Stage I or II (T1 or T2, N0 or non-hilar N1, M0) disease * Any of the following histologies allowed: * Squamous cell carcinoma * Adenocarcinoma (\< 10%) * Large cell carcinoma (high-grade) * Available tumor tissue samples collected on clinical trial ACOSOG-Z0030 and meeting the following criteria: * Snap-frozen and stored at a temperature of -80°C or lower * Specimens may come from any site within the lung or one that is involved by direct regional extension of tumor from the originating site in the lung * No regional lymph node or distant metastases * No recurrent or persistent disease after prior neoadjuvant or adjuvant treatment for lung cancer * Must have matching frozen samples of normal tissue and blood

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

Tumor samples from patients enrolled on Z0030.

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Carcinoma, Non-Small-Cell Lung

Interventions

Microarray Analysis; Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mark Allen, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: February 1, 2013
• Last Updated: June 29, 2016

Record last verified: 2016-06