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



Status:Recruiting
Conditions:Lung Cancer, Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:21 - 90
Updated:6/27/2018
Start Date:March 2002
End Date:May 2019

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Biomarkers and Dysplastic Respiratory Epithelium

RATIONALE: Studying samples of sputum and tissue in the laboratory from patients with
dysplasia or cancer and from normal volunteers 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 and in normal
volunteers.

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.

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 dysplasia (normal volunteers)

- 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

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics
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