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RecruitingNCT00900419Updated Sep 22, 2025

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

An observational study in Esophageal Cancer, Head and Neck Cancer and Lung Cancer, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by University of Colorado, Denver · Observational

From the registry’s dates

  • Started May 2001; still recruiting 25 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
700
Ages
21 Years to 90 Years
Sex
All
01

Study summary

RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with dysplasia or cancer 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.

Read the detailed description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

02

Conditions studied

  • Esophageal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Precancerous Condition

Keywords

  • 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
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.

This study's planned enrollment of 700 is above the median of 200 across 341 observational studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

High Risk for Lung Cancer, suspected lung cancer, lung cancer.

Eligibility criteria

Inclusion Criteria:

  • Diagnosis of extensive and severe dysplasia of the respiratory epithelium
  • Those without 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 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.
    • Patients without dysplasia will be: patients undergoing clinically indicated bronchoscopy for conditions other than suspected lung cancer.

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Otherimmunohistochemistry staining method

    Laboratory test

  • Otherlaboratory biomarker analysis

    Laboratory Test

  • Othersputum cytology

    Laboratory Test

  • Procedurebiopsy

    Laboratory Test

06

What researchers measure

Primary outcomes

  1. Genetic mutations or altered growth factor expression

    Time frame: After study has completed

Secondary outcomes

  1. Establishment of a tissue repository of normal and dysplastic respiratory epithelium

    Time frame: After study has closed

07

Study locations

1 of 1 sites recruiting
  • University of Colorado Cancer Center at UC Health Sciences Center
    Aurora, Colorado 80045, United States
    • Clinical Trials Office - University of Colorado Cancer Center · Contact · 303-724-1657
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00900419
Lead sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
May 12, 2009
Start date
May 3, 2001
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Sep 22, 2025

Study contacts

Brandi Kubala
Contact
brandi.kubala@cuanschutz.edu
303-724-1657
York E. Miller, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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