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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Genetic: DNA/RNA sequencing and expression levels; Genetic: Protein expression analysis; Procedure: Lung tumor biopsy; Procedure: 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.

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-6838
      • Vanderbilt-Ingram Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 120 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People who have or may have lung cancer.

Description

Inclusion criteria

• Diagnosis of suspected lung cancer or lung cancer

Exclusion criteria

• Inability to undergo therapy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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: Immunohistochemistry; Western blot; Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI); 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Christine Lovly, MD, PhD, Vanderbilt-Ingram Cancer Center

Publications and helpful links

Helpful Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 9, 2009
• First Submitted That Met QC Criteria: May 9, 2009
• First Posted (Estimate): May 12, 2009

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: VICC THO 0547; P30CA068485 (U.S. NIH Grant/Contract); P50CA090949 (U.S. NIH Grant/Contract); VU-VICC-THO-0547 (Other Identifier: VICC)