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

Launched by UNIVERSITY OF COLORADO, DENVER · May 9, 2009

Keywords

ClinConnect Summary

This clinical trial is studying biomarkers, which are indicators in the body that can help us understand more about certain cancers, especially in the respiratory tract. The goal is to gather samples from patients who have been diagnosed with conditions like lung cancer, head and neck cancer, or severe dysplasia (a precancerous condition), as well as from normal volunteers. By analyzing these samples in the lab, researchers hope to learn more about how these cancers develop and potentially improve future treatments.

To participate in this study, individuals need to meet specific criteria. For example, they should have a diagnosis of severe dysplasia or have survived a type of head and neck cancer for at least a year. Other eligibility requirements include undergoing certain medical procedures like bronchoscopy (a test to look inside the lungs) and having no major respiratory or heart conditions. Participants can expect to provide samples through these procedures, which will help in the research of cancer biomarkers. This study is currently recruiting participants, and it is open to everyone regardless of gender, as long as they meet the health requirements outlined.

Gender

ALL

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