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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment
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

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Study Type :	Observational
Estimated Enrollment :	500 participants
Observational Model:	Other
Time Perspective:	Prospective
Official Title:	Biomarkers and Dysplastic Respiratory Epithelium
Study Start Date :	March 2002
Estimated Primary Completion Date :	May 2018
Estimated Study Completion Date :	May 2018

Groups and Cohorts

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Intervention Details:

Other: immunohistochemistry staining method
Laboratory test
Other: laboratory biomarker analysis
Laboratory Test
Other: sputum cytology
Laboratory Test
Procedure: biopsy
Laboratory Test

Outcome Measures

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Primary Outcome Measures :

1. Genetic mutations or altered growth factor expression [ Time Frame: After study has completed ]

Secondary Outcome Measures :

1. Establishment of a tissue repository of normal and dysplastic respiratory epithelium [ Time Frame: After study has closed ]

Biospecimen Retention:   Samples With DNA

Sputum sample,Endobronchial biopsy, bronchial secretions, pulmonary labage, blood and urine, buccal smears,exhaled breath collection.

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

High Risk for Lung Cancer, suspected lung cancer, lung cancer.

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

Contacts and Locations

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Locations

United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center	Recruiting
Aurora, Colorado, United States, 80045
Contact: Clinical Trials Office - University of Colorado Cancer Center 303-724-1650

Sponsors and Collaborators

University of Colorado, Denver

National Cancer Institute (NCI)

Investigators

Principal Investigator:	York E. Miller, MD	University of Colorado, Denver

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Colorado, Denver
ClinicalTrials.gov Identifier:	NCT00900419 History of Changes
Other Study ID Numbers:	00-1108; SPORE 24 ( Other Identifier: SPORE Number ); P50CA058187 ( U.S. NIH Grant/Contract )
First Posted:	May 12, 2009
Last Update Posted:	August 30, 2017
Last Verified:	August 2017

Keywords provided by University of Colorado, Denver:

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

Additional relevant MeSH terms:

Lung Neoplasms; Head and Neck Neoplasms; Esophageal Neoplasms; Precancerous Conditions; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms	Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases