RecruitingNot applicableNCT00900419
Official study title

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

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedimmunohistochemistry staining method and laboratory biomarker analysis

Plus 2 other study approaches.

Who it may be forEsophageal Cancer · Head and Neck Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 22, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Colorado, Denver

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
University of Colorado, Denver
Interventions being studied
Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: sputum cytology; Procedure: biopsy
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 22, 2025. Always confirm current availability with the study team.

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