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Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants

Identification and Validation of Molecular Markers in Lung Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00899028
Enrollment
689
Registered
2009-05-12
Start date
2001-05-31
Completion date
2016-08-31
Last updated
2017-04-20

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

Conditions

Lung Cancer

Keywords

stage 0 non-small cell lung cancer, stage I non-small cell lung cancer, extensive stage small cell lung cancer, limited stage small cell lung cancer, stage II non-small cell lung cancer, stage IV non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Brief summary

RATIONALE: Studying samples of tissue, blood, sputum, and urine from patients with lung cancer and from healthy participants in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at biomarkers for lung cancer using tissue samples from patients with lung cancer and from healthy participants.

Detailed description

OBJECTIVES: * To identify new molecular abnormalities specific to the development of squamous cell carcinoma of the lung. * To determine the prevalence of candidate biomarkers in lung cancer progression. * To determine the odds of developing lung cancer according to biomarker status in preinvasive lesions. * To determine the odds of developing lung cancer according to proteomic biomarker status in the normal bronchial epithelium of high-risk patients. OUTLINE: This is a multicenter study. Tissue samples are collected at the time of fluorescence bronchoscopy for laboratory biomarker studies. Blood, sputum, and urine samples are also collected. Gene and protein expression studies are performed on the samples using comparative genomic hybridization array, 3q oligonucleotide microarray, matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF), fluorescence in situ hybridization (FISH), and immunohistochemistry (IHC). Patients' medical records are reviewed to collect information about the patient's past medical history and pertinent laboratory and radiography results. Patients and healthy volunteers are followed annually via telephone or a mailed questionnaire.

Interventions

GENETICcomparative genomic hybridization
GENETICfluorescence in situ hybridization
GENETICgene expression analysis
GENETICmicroarray analysis
GENETICprotein expression analysis
OTHERimmunohistochemistry staining method
OTHERlaboratory biomarker analysis
OTHERmedical chart review

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt University Medical Center
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
Yes

Inclusion criteria

DISEASE CHARACTERISTICS: * Meets 1 of the following criteria: * Known or previously diagnosed lung cancer * Suspected lung cancer, including the following: * Completely resected stage I lung cancer (with no evidence of metastatic disease) for which patient is at risk for developing secondary disease * Suspected of having lung cancer due to clinical symptoms, such as positive sputum cytology, hemoptysis, unresolved pneumonia, persistent cough, and positive x-ray * Healthy volunteer PATIENT CHARACTERISTICS: * WBC ≥ 2,000/mm³ but ≤ 20,000/mm³ * Platelet count ≥ 50,000/mm³ * Not pregnant * No uncontrolled hypertension (i.e., systolic blood pressure \> 200 mm Hg, diastolic blood pressure \> 120 mm Hg) * No unstable angina * No known bleeding disorder * No other contraindications for white light bronchoscopic examination * No other contraindications for fluorescence examination PRIOR CONCURRENT THERAPY: * More than 3 months since prior fluorescent photosensitizing agents (hematoporphyrin derivatives) * More than 3 months since prior and no concurrent chemopreventative drugs (e.g., tretinoin) * More than 6 months since prior ionizing radiation treatment to the chest * More than 6 months since prior systemic cytotoxic chemotherapy * No concurrent anticoagulant therapy

Design outcomes

Primary

MeasureTime frame
Identification of new molecular markers specific to the development of squamous cell lung cancer
Prevalence of candidate biomarkers in lung cancer progression
Odds of developing lung cancer according to biomarker status

Countries

United States

Outcome results

None listed

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