Clinical trial NCT00900419: Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Official title: Biomarkers and Dysplastic Respiratory Epithelium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Precancerous Condition
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
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 700
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High Risk for Lung Cancer, suspected lung cancer, lung cancer.

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.

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.

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

Primary outcomes:
measure: Genetic mutations or altered growth factor expression
timeFrame: After study has completed
Secondary outcomes:
measure: Establishment of a tissue repository of normal and dysplastic respiratory epithelium
timeFrame: After study has closed
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Cancer Center at UC Health Sciences Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: York E. Miller, MD
role: PRINCIPAL_INVESTIGATOR
References: