Recruiting

Biomarkers

Sponsor:

University of Colorado, Denver

Code:

NCT00900419

Conditions

Esophageal Cancer

Head and Neck Cancer

Lung Cancer

Precancerous Condition

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

immunohistochemistry staining method

laboratory biomarker analysis

sputum cytology

biopsy

Study Details

Brief 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.

Conditions

Esophageal Cancer

Head and Neck Cancer

Lung Cancer

Precancerous Condition

Study ID

NCT00900419

Start date

May 3, 2001

Status verified date

Sep, 2025

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

700 participants

Anticipated

Interventions and Outcome Measures

Interventions

immunohistochemistry staining method

Laboratory test

laboratory biomarker analysis

Laboratory Test

sputum cytology

Laboratory Test

biopsy

Laboratory Test

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Brandi Kubala

303-724-1657brandi.kubala@cuanschutz.edu

Locations

University of Colorado Cancer Center at UC Health Sciences Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Clinical Trials Office - University of Colorado Cancer Center

303-724-1657

More Information

Sponsor

University of Colorado, Denver

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-09-22.