Identifying cancer biomarkers in patients with respiratory tract conditions
Biomarkers and Dysplastic Respiratory Epithelium
This study is trying to find specific markers in patients with lung and throat cancers, as well as other respiratory issues, to see if they can help identify early signs of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT00900419 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate biomarkers in patients diagnosed with respiratory tract dysplasia, lung cancer, head and neck cancer, or aerodigestive tract cancer. Participants will undergo various procedures, including sputum cytology and bronchoscopy, to collect samples for laboratory analysis. The study will focus on identifying genetic mutations and altered growth factor expressions that may indicate premalignant lesions. Additionally, a tissue repository will be established to store samples from both patients and normal volunteers for future research.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with extensive and severe dysplasia of the respiratory epithelium or those with a history of aerodigestive tract cancers.
Not a fit: Patients with asthma, lung disease, or recent respiratory illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of cancer biomarkers, leading to improved diagnosis and treatment strategies for patients with respiratory tract cancers.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for lung and head and neck cancers, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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. * 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 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
Where this trial is running
Aurora, Colorado
- University of Colorado Cancer Center at UC Health Sciences Center — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: York E. Miller, MD — University of Colorado, Denver
- Study coordinator: Brandi Kubala
- Email: brandi.kubala@cuanschutz.edu
- Phone: 303-724-1657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.