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Biomarkers and Dysplastic Respiratory Epithelium


Phase 2
21 Years
90 Years
Open (Enrolling)
Both
Esophageal Cancer, Head and Neck Cancer, Lung Cancer, Precancerous Condition

Thank you

Trial Information

Biomarkers and Dysplastic Respiratory Epithelium


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Genetic mutations or altered growth factor expression

Outcome Time Frame:

After study has completed

Safety Issue:

No

Principal Investigator

York E. Miller, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Colorado, Denver

Authority:

United States: Institutional Review Board

Study ID:

00-1108

NCT ID:

NCT00900419

Start Date:

March 2002

Completion Date:

May 2014

Related Keywords:

  • Esophageal Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Precancerous Condition
  • 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
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Precancerous Conditions

Name

Location
University of Colorado Cancer Center at UC Health Sciences Center Aurora, Colorado  80045