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Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers

This study is currently recruiting participants.
Verified August 2017 by University of Colorado, Denver
ClinicalTrials.gov Identifier:
First Posted: May 12, 2009
Last Update Posted: August 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Colorado, Denver

RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with dysplasia or cancer and from normal volunteers may help doctors identify and learn more about biomarkers related to cancer. It may also help the study of cancer in the future.

PURPOSE: This laboratory study is looking at biomarkers in patients with respiratory tract dysplasia or lung cancer, head and neck cancer, or aerodigestive tract cancer and in normal volunteers.

Condition Intervention
Esophageal Cancer Head and Neck Cancer Lung Cancer Precancerous Condition Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: sputum cytology Procedure: biopsy

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Biomarkers and Dysplastic Respiratory Epithelium

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Genetic mutations or altered growth factor expression [ Time Frame: After study has completed ]

Secondary Outcome Measures:
  • Establishment of a tissue repository of normal and dysplastic respiratory epithelium [ Time Frame: After study has closed ]

Biospecimen Retention:   Samples With DNA
Sputum sample,Endobronchial biopsy, bronchial secretions, pulmonary labage, blood and urine, buccal smears,exhaled breath collection.

Estimated Enrollment: 500
Study Start Date: March 2002
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: immunohistochemistry staining method
    Laboratory test
    Other: laboratory biomarker analysis
    Laboratory Test
    Other: sputum cytology
    Laboratory Test
    Procedure: biopsy
    Laboratory Test
Detailed Description:



  • Determine intermediate biomarkers of premalignant respiratory epithelial lesions, such as genetic mutations or altered growth factor expression, in patients with dysplasia of the respiratory epithelium or lung cancer, head and neck cancer, or aerodigestive tract cancer.


  • Establish a tissue repository of normal and dysplastic respiratory epithelium from endobronchial forceps and brush biopsy tissue from these patients and from normal volunteers.

OUTLINE: Patients are stratified according to presence of extensive and severe dysplasia of the respiratory epithelium (yes vs no).

Participants undergo sputum cytology, white-light (with or without fluorescence) bronchoscopy, and endobronchial biopsies. Participants also undergo endobronchial brushings and bronchial secretion collection and possibly bronchoalveolar lavage. Collected samples are processed by hematoxylin, eosin, and immunohistochemical staining and analyzed for specific biomarkers. Unused samples are stored in the tissue bank.

PROJECTED ACCRUAL: A total of 330 participants will be accrued for this study.


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
High Risk for Lung Cancer, suspected lung cancer, lung cancer.


  • Meets any of the following criteria:

    • Diagnosis of extensive and severe dysplasia of the respiratory epithelium

      • Recruited from the SPORE Tissue Procurement Screening Project or by private or academic physicians (for patients with moderate or severe dysplasia)
    • Survived 1 or more aerodigestive system carcinoma for ≥ 1 year
    • Completely resected stage I non-small cell cancer
    • Undergoing any of the following procedures:

      • Routine panendoscopy for patients with head and neck cancer
      • Resection of a bronchogenic carcinoma
      • Bronchoscopy for diagnosis or staging of suspected lung cancer
      • Subsequent bronchoscopy for surveillance or monitoring of response to endobronchial treatment in patients with prior high-grade dysplasia or worse
    • No dysplasia (normal volunteers)

      • No asthma
      • No lung disease
      • No respiratory illness within the past 2 weeks Patients suspected of or at risk for neoplastic lung disease who are undergoing a bronchoscopy in which differential diagnostic considerations may include multiple other etiologies such as infection and other processes.


  • No clinically apparent bleeding diathesis
  • No known bleeding disorder
  • No anginal
  • No clinically active coronary artery disease
  • No multifocal premature ventricular contractions
  • No poorly controlled congestive heart failure
  • No myocardial infarction within the past 6 weeks
  • No cardiac dysrhythmia that is potentially life threatening
  • Well-controlled atrial fibrillation or rare (< 2/min) premature ventricular contractions allowed
  • No ventricular tachycardia or supraventricular tachycardia with a rapid ventricular response
  • No other serious medical condition that would preclude a patient from undergoing a bronchoscopy
  • No acute bronchitis or pneumonia within the past 8 weeks except when clinically proven as a possible result of lung cancer
  • No hypoxemia (i.e., < 90% saturation with supplemental oxygen) before bronchoscopy


  • See Disease Characteristics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900419

United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center    303-724-1650      
Sponsors and Collaborators
University of Colorado, Denver
National Cancer Institute (NCI)
Principal Investigator: York E. Miller, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00900419     History of Changes
Other Study ID Numbers: 00-1108
SPORE 24 ( Other Identifier: SPORE Number )
P50CA058187 ( U.S. NIH Grant/Contract )
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: August 30, 2017
Last Verified: August 2017

Keywords provided by University of Colorado, Denver:
non-small cell lung cancer
small cell lung cancer
squamous lung dysplasia
hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
metastatic squamous neck cancer with occult primary
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
salivary gland cancer
esophageal cancer
pulmonary carcinoid tumor
tongue cancer

Additional relevant MeSH terms:
Lung Neoplasms
Head and Neck Neoplasms
Esophageal Neoplasms
Precancerous Conditions
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases