Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer
|ClinicalTrials.gov Identifier: NCT00897650|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : July 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Lung Cancer||Genetic: DNA/RNA sequencing and expression levels Genetic: Protein expression analysis Procedure: Lung tumor biopsy Procedure: Blood sample|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||204 participants|
|Official Title:||Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2017|
Patients with a diagnosis of invasive lung cancer.
Genetic: DNA/RNA sequencing and expression levels
Lung tumor tissue will be collected.
Genetic: Protein expression analysis
Lung tumor tissue will be collected.
Procedure: Lung tumor biopsy
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
Procedure: Blood sample
Patients will be asked for a venous blood sample
- DNA, RNA, and Protein expression patterns and mutational analysis [ Time Frame: After lung tumor tissue and blood collection. ]DNA, RNA, and Protein expression patterns and mutation status in lung tumor tissue that are capable of predicting tumor response to therapy
- Characterization of genes and proteins predictive of response to therapy [ Time Frame: After lung tumor tissue and blood collection ]Identify genes and proteins predictive of response to therapy and that can be used to identify novel mechanisms underlying lung cancer behavior
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897650
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Study Chair:||Christine Lovly, MD, PhD||Vanderbilt-Ingram Cancer Center|