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

Completed

• Conditions: Lung Cancer
• Interventions: Genetic: DNA/RNA sequencing and expression levels; Genetic: Protein expression analysis; Procedure: Lung tumor biopsy; Procedure: Blood sample

• Registration Number: NCT00897650
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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

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 Timeline

• Study Start: 2005-12
• Study First Submitted: 2009-05-09
• Study First Submitted QC: 2009-05-09
• Study First Posted: 2009-05-12
• Primary Completion: 2016-07
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-18
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lung cancer	Protein expression analysis	Patients with a diagnosis of invasive lung cancer.
Lung cancer	DNA/RNA sequencing and expression levels	Patients with a diagnosis of invasive lung cancer.
Lung cancer	Blood sample	Patients with a diagnosis of invasive lung cancer.
Lung cancer	Lung tumor biopsy	Patients with a diagnosis of invasive lung cancer.

Primary Outcome Measures

Name	Time	Method
DNA, RNA, and Protein expression patterns and mutational analysis	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

Secondary Outcome Measures

Name	Time	Method
Characterization of genes and proteins predictive of response to therapy	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

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States