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OpenTrials
Completed

NCT Number: NCT00897650

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

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.

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Key information

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of suspected lung cancer or lung cancer

Exclusion criteria

  • Inability to undergo therapy

Treatment and study plan

DNA/RNA sequencing and expression levels

Genetic

Lung tumor tissue will be collected.

protein expression analysis

Genetic

Lung tumor tissue will be collected.

Other names: Matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI), Immunohistochemistry, Western blot, RPPA

Lung tumor biopsy

Procedure

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

Procedure

Patients will be asked for a venous blood sample

Primary outcomes

  1. DNA, RNA, and Protein expression patterns and mutational analysis

    Time frame: 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 outcomes

  1. Characterization of genes and proteins predictive of response to therapy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Molecular Fingerprints in Lung Cancer: Predicting Tumor Response to Therapy

Important dates

Study start
2005
Primary completion
2016
Study completion
2017
First posted
May 12, 2009
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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