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
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

Lung tumor tissue and blood samples will be collected.


Estimated Enrollment: 400
Study Start Date: December 2005
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lung cancer
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.
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

People who have or may have lung cancer.

Criteria

Inclusion criteria

  • Diagnosis of suspected lung cancer or lung cancer

Exclusion criteria

  • Inability to undergo therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897650

Contacts
Contact: VICC Clinical Trial Information Program 800-811-8480

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program    800-811-8480      
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: VICC Clinical Trials Information Program    800-811-8480      
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center    800-811-8480      
Principal Investigator: Christine Lovly, MD, PhD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
Study Chair: Christine Lovly, MD, PhD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Christine Lovly, MD, PhD, Assistant Professor of Medicine and Cancer Biology, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00897650     History of Changes
Other Study ID Numbers: VICC THO 0547, P30CA068485, VU-VICC-THO-0547, P50CA090949
Study First Received: May 9, 2009
Last Updated: June 18, 2014
Health Authority: United States: Vanderbilt University Human Research Protection Program

Keywords provided by Vanderbilt-Ingram Cancer Center:
lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014