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

Lung Cancer Clinical Trial

Official title:

Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00897650
• Other study ID #: VICC THO 0547
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: July 18, 2017
• Start date: December 2005
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

Inclusion criteria

• Diagnosis of suspected lung cancer or lung cancer

Exclusion criteria

• Inability to undergo therapy

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• DNA/RNA sequencing and expression levels
Lung tumor tissue will be collected.
• 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
• Blood sample
Patients will be asked for a venous blood sample

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial