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

NCT00899028 | Completed

• 5 other identifiers: CDR0000584223R01CA102353P30CA068485VU-VICC-THO-0373VU-VICC-010178
• Study Type: observational
• Target: 689
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

comparative genomic hybridization GENETIC

fluorescence in situ hybridization GENETIC

gene expression analysis GENETIC

microarray analysis GENETIC

protein expression analysis GENETIC

immunohistochemistry staining method OTHER

laboratory biomarker analysis OTHER

matrix-assisted laser desorption/ionization time of flight mass spectrometry OTHER

medical chart review OTHER

diagnostic bronchoscopy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Veterans Affairs Medical Center - Nashville

Nashville, Tennessee, 37212, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Comparative Genomic Hybridization; In Situ Hybridization, Fluorescence; Gene Expression Profiling; Microarray Analysis; Immunohistochemistry

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Cytogenetic Analysis; Genetic Techniques; Investigative Techniques; Molecular Diagnostic Techniques; Nucleic Acid Hybridization; In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Microchip Analytical Procedures; Histocytochemistry; Immunologic Techniques

Study Officials

• Pierre P. Massion, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: May 1, 2001
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (4)