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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Vanderbilt-Ingram Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christine Lovly, MD, PhD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00897650
First received: May 9, 2009
Last updated: June 18, 2014
Last verified: June 2014

May 9, 2009
June 18, 2014
December 2005
December 2019   (final data collection date for primary outcome measure)
DNA, RNA, and Protein expression patterns and mutational analysis [ Time Frame: After lung tumor tissue and blood collection. ] [ Designated as safety issue: No ]
DNA, RNA, and Protein expression patterns and mutation status in lung tumor tissue that are capable of predicting tumor response to therapy
  • Protein and/or RNA expression patterns [ Designated as safety issue: No ]
  • Characterization of genes and proteins predictive of response [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897650 on ClinicalTrials.gov Archive Site
Characterization of genes and proteins predictive of response to therapy [ Time Frame: After lung tumor tissue and blood collection ] [ Designated as safety issue: No ]
Identify genes and proteins predictive of response to therapy and that can be used to identify novel mechanisms underlying lung cancer behavior
Not Provided
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Protein and RNA Expression Patterns in Predicting Response to Treatment in Patients With Lung Cancer
Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Lung tumor tissue and blood samples will be collected.

Non-Probability Sample

People who have or may have lung cancer.

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.
    Other Names:
    • Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI)
    • Immunohistochemistry
    • Western blot
    • RPPA
  • 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
Lung cancer
Patients with a diagnosis of invasive lung cancer.
Interventions:
  • Genetic: DNA/RNA sequencing and expression levels
  • Genetic: Protein expression analysis
  • Procedure: Lung tumor biopsy
  • Procedure: Blood sample
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
Not Provided
December 2019   (final data collection date for primary outcome measure)

Inclusion criteria

  • Diagnosis of suspected lung cancer or lung cancer

Exclusion criteria

  • Inability to undergo therapy
Both
Not Provided
No
Contact: VICC Clinical Trial Information Program 800-811-8480
United States
 
NCT00897650
VICC THO 0547, P30CA068485, VU-VICC-THO-0547, P50CA090949
No
Christine Lovly, MD, PhD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Study Chair: Christine Lovly, MD, PhD Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP