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

Lung Cancer Clinical Trial

Official title:

Identification and Validation of Molecular Markers in Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899028
• Other study ID #: CDR0000584223
• Secondary ID: R01CA102353P30CA
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: April 19, 2017
• Start date: May 2001
• Est. completion date: August 2016

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Genetic:
• comparative genomic hybridization

• fluorescence in situ hybridization

• gene expression analysis

• microarray analysis

• protein expression analysis

Other:
• immunohistochemistry staining method

• laboratory biomarker analysis

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

• medical chart review

Procedure:
• diagnostic bronchoscopy

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee
United States	Veterans Affairs Medical Center - Nashville	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of new molecular markers specific to the development of squamous cell lung cancer
Primary	Prevalence of candidate biomarkers in lung cancer progression
Primary	Odds of developing lung cancer according to biomarker status