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Identification and Validation of Molecular Markers in Lung Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Identification and Validation of Molecular Markers in Lung Cancer


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Identification of new molecular markers specific to the development of squamous cell lung cancer

Safety Issue:

No

Principal Investigator

Pierre P. Massion, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

Unspecified

Study ID:

CDR0000584223

NCT ID:

NCT00899028

Start Date:

May 2001

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Lung Neoplasms

Name

Location

Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Veterans Affairs Medical Center - NashvilleNashville, Tennessee  37212
Vanderbilt-Ingram Cancer Center - Cool SpringsNashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at FranklinNashville, Tennessee  37064