Laboratory Study Using Samples From Patients With Non-Small Cell Lung Cancer Treated on Clinical Trial CASE-2507

NCT00907699 | Withdrawn DMC

• 2 other identifiers: CASE9507P30CA043703
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and RNA and identify biomarkers related to cancer. PURPOSE: This laboratory study is looking at biomarkers in tumor tissue and blood samples from patients with non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (5)

• Predictive value of T790M mutation status of the second biopsy (before maintenance therapy on CASE-2507) on progression-free survival (PFS)

  At the time of the second biopsy or surgical procedures

• Difference of PFS between those with and without T790M mutation

  At the time of the second biopsy or surgical procedures

• Difference of clinical response rate between T790M mutation statuses

  At the time of the second biopsy or surgical procedures

• Predictive value of mutation status on clinical response

  At the time of the second biopsy or surgical procedures

• Association between T790M mutation and baseline clinical-pathological factors and smoking status

  At the time of the second biopsy or surgical procedures

Interventions

DNA analysis GENETIC

DNA is extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways.

RNA analysis GENETIC

RNA is extracted from tumor samples. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

fluorescence in situ hybridization GENETIC

DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

gene expression analysis GENETIC

DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

mutation analysis GENETIC

DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

polymerase chain reaction GENETIC

DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

reverse transcriptase-polymerase chain reaction GENETIC

DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

laboratory biomarker analysis OTHER

DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

Eligibility Criteria

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

Study Population

Primary Care Clinic

DISEASE CHARACTERISTICS: * Eligible for and concurrently enrolled on clinical trial CASE-2507 PATIENT CHARACTERISTICS: * Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * Normal coagulation profile and platelet count \> 100,000/mm³\* * Not pregnant NOTE: \*For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy. PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent anticoagulants (e.g., warfarin or low-molecular weight heparin) * No concurrent antiplatelet therapy (e.g., aspirin, clopidogrel, or other antiplatelet agents)\* NOTE: \*For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

This laboratory study is looking at biomarkers in tumor tissue and blood samples from patients with non-small cell lung cancer.

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

In Situ Hybridization, Fluorescence; Gene Expression Profiling; Polymerase Chain Reaction; 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)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Nucleic Acid Amplification Techniques

Study Officials

• Afshin Dowlati, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 22, 2009
• Study Start: August 1, 2008
• Primary Completion: February 1, 2013
• Last Updated: July 24, 2014

Record last verified: 2014-07