Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in genetic material (DNA and RNA) and may also identify protein expression patterns related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study evaluates changes in DNA, RNA, and proteins with the goal of predicting response to treatment in patients with lung cancer.

Detailed Description
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OBJECTIVES: To determine protein and/or RNA expression patterns capable of predicting tumor response to therapy in tumor tissue samples from patients with lung cancer or suspected of having lung cancer. To characterize the genes and proteins found to be predictive of response in order to help elucidate the molecular biology underlying cancer chemosensitivity. To evaluate DNA mutations found within the lung cancer sample which may be predictive of response or resistance to certain therapeutic agents. OUTLINE: Patients undergo collection of tumor tissue by percutaneous fine needle aspiration, core biopsy, thoracentesis, or during any medically indicated procedure involving removal of lung cancer tissue. Tissue samples are analyzed by a variety of techniques, including DNA sequencing, RNA sequencing and expression levels, protein assessment [by immunohistochemistry, western blot, Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-MS]). The goal of these studies is to identify of gene mutations, gene expression levels, and proteins predictive of treatment response. Blood samples are also collected to obtain normal DNA for analysis. After completion of study, patients will be followed until their death.

Official Title
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Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy

Conditions
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Lung Cancer

Intervention / Treatment
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* Genetic: DNA/RNA sequencing and expression levels
* Genetic: Protein expression analysis
* Procedure: Lung tumor biopsy
* Procedure: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Diagnosis of suspected lung cancer or lung cancer Exclusion criteria Inability to undergo therapy

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer<br>Patients with a diagnosis of invasive lung cancer. | Genetic: DNA/RNA sequencing and expression levels<br>* Lung tumor tissue will be collected.<br>Genetic: Protein expression analysis<br>* Lung tumor tissue will be collected.<br>* Other names: RPPA;Procedure: Lung tumor biopsy<br>* Tissue will be collected by percutaneous fine needle aspiration, a percutaneous core biopsy, or during a medically indicated procedure during which lung tumor tissue will be removed<br>Procedure: Blood sample<br>* Patients will be asked for a venous blood sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DNA, RNA, and Protein expression patterns and mutational analysis | DNA, RNA, and Protein expression patterns and mutation status in lung tumor tissue that are capable of predicting tumor response to therapy | After lung tumor tissue and blood collection. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of genes and proteins predictive of response to therapy | Identify genes and proteins predictive of response to therapy and that can be used to identify novel mechanisms underlying lung cancer behavior | After lung tumor tissue and blood collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer