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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Recruiting

CT.gov ID

NCT00900419

Collaborator

National Cancer Institute (NCI) (NIH)

700

Enrollment

Location

271

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer Head and Neck Cancer Lung Cancer Precancerous Condition	Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: sputum cytology Procedure: biopsy

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 Design

Study Type:

Observational

Anticipated Enrollment :

700 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Biomarkers and Dysplastic Respiratory Epithelium

Study Start Date :

Mar 1, 2002

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Outcome Measures

Primary Outcome Measures

Genetic mutations or altered growth factor expression [After study has completed]

Secondary Outcome Measures

Establishment of a tissue repository of normal and dysplastic respiratory epithelium [After study has closed]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Meets any of the following criteria:
Diagnosis of extensive and severe 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.

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