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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00897650
Enrollment
204
Registered
2009-05-12
Start date
2005-12-31
Completion date
2017-07-31
Last updated
2017-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

lung cancer

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.

Interventions

GENETICDNA/RNA sequencing and expression levels

Lung tumor tissue will be collected.

GENETICProtein expression analysis

Lung tumor tissue will be collected.

PROCEDURELung 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

PROCEDUREBlood sample

Patients will be asked for a venous blood sample

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosis of suspected lung cancer or lung cancer

Exclusion criteria

* Inability to undergo therapy

Design outcomes

Primary

MeasureTime frameDescription
DNA, RNA, and Protein expression patterns and mutational analysisAfter 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

MeasureTime frameDescription
Characterization of genes and proteins predictive of response to therapyAfter lung tumor tissue and blood collectionIdentify genes and proteins predictive of response to therapy and that can be used to identify novel mechanisms underlying lung cancer behavior

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026