Identifying Biomarkers for Lung Cancer Using Tissue Samples From Patients With Lung Cancer and From Healthy Participants
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899028
First received: May 9, 2009
Last updated: August 11, 2009
Last verified: October 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Lung Cancer |
Genetic: comparative genomic hybridization Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: microarray analysis Genetic: protein expression analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry Other: medical chart review Procedure: diagnostic bronchoscopy |
| Study Type: | Observational |
| Official Title: | Identification and Validation of Molecular Markers in Lung Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Identification of new molecular markers specific to the development of squamous cell lung cancer [ Designated as safety issue: No ]
- Prevalence of candidate biomarkers in lung cancer progression [ Designated as safety issue: No ]
- Odds of developing lung cancer according to biomarker status [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | May 2001 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899028
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Pierre P Massion 615-322-3412 | |
| Vanderbilt-Ingram Cancer Center at Franklin | Recruiting |
| Nashville, Tennessee, United States, 37064 | |
| Contact: Pierre P Massion 615-322-3412 | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480 | |
| Veterans Affairs Medical Center - Nashville | Recruiting |
| Nashville, Tennessee, United States, 37212 | |
| Contact: Clinical Trials Office - Veterans Affairs Medical Center - Nas 615-327-4751 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Study Chair: | Pierre P. Massion, MD | Vanderbilt-Ingram Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00899028 History of Changes |
| Other Study ID Numbers: | CDR0000584223, VU-VICC-THO-0373, VU-VICC-010178 |
| Study First Received: | May 9, 2009 |
| Last Updated: | August 11, 2009 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013