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

NCT ID: NCT00900419

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-05-03
• Study Completion Date: 2027-09-30

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.

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

immunohistochemistry staining method

Laboratory test

Intervention Type: OTHER

laboratory biomarker analysis

Laboratory Test

Intervention Type: OTHER

sputum cytology

Laboratory Test

Intervention Type: OTHER

biopsy

Laboratory Test

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

York E. Miller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brandi Kubala

Role: CONTACT

brandi.kubala@cuanschutz.edu

303-724-1657

Facility Contacts

Clinical Trials Office - University of Colorado Cancer Center

Role: primary

303-724-1657

Other Identifiers

SPORE 24

Identifier Type: OTHER

Identifier Source: secondary_id

P50CA058187

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00-1108.cc

Identifier Type: -

Identifier Source: org_study_id