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

September 16, 2025 updated by: University of Colorado, Denver

Biomarkers and Dysplastic Respiratory Epithelium

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Brandi Kubala
Phone Number: 303-724-1657
Email: brandi.kubala@cuanschutz.edu

Study Locations

United States
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - University of Colorado Cancer Center at UC Health Sciences Center
    - Contact:
      
      Clinical Trials Office - University of Colorado Cancer Center
      
      Phone Number: 303-724-1657

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Genetic mutations or altered growth factor expression Time Frame: After study has completed	After study has completed

Secondary Outcome Measures

Outcome Measure	Time Frame
Establishment of a tissue repository of normal and dysplastic respiratory epithelium Time Frame: After study has closed	After study has closed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: York E. Miller, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2001

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria