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

NCT ID: NCT00897650

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

204 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung cancer

Patients with a diagnosis of invasive lung cancer.

DNA/RNA sequencing and expression levels

Intervention Type GENETIC

Lung tumor tissue will be collected.

Protein expression analysis

Intervention Type GENETIC

Lung tumor tissue will be collected.

Lung tumor biopsy

Intervention Type 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

Intervention Type PROCEDURE

Patients will be asked for a venous blood sample

Interventions

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DNA/RNA sequencing and expression levels

Lung tumor tissue will be collected.

Intervention Type GENETIC

Protein expression analysis

Lung tumor tissue will be collected.

Intervention Type GENETIC

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

Intervention Type PROCEDURE

Blood sample

Patients will be asked for a venous blood sample

Intervention Type PROCEDURE

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of suspected lung cancer or lung cancer

Exclusion Criteria

* Inability to undergo therapy
Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Christine Lovly, MD, PhD

Assistant Professor of Medicine and Cancer Biology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christine Lovly, MD, PhD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Locations

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Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Related Links

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http://www.vicc.org/ct/

Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

Other Identifiers

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P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-THO-0547

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA090949

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VICC THO 0547

Identifier Type: -

Identifier Source: org_study_id

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