NCT00900419 · University of Colorado, Denver
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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.
- Patients without dysplasia will be: patients undergoing clinically indicated bronchoscopy for conditions other than suspected lung cancer. PATIENT CHARACTERISTICS:
- No clinically apparent bleeding diathesis
- No known bleeding disorder
- 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
Where
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2025 · Source of record for eligibility and locations