Identifying cancer biomarkers in patients with respiratory tract conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Two broad patient groups are of interest: those with extensive and severe dysplasia of the respiratory epithelium and those without dysplasia of the respiratory epithelium. The patients with dysplasia will be recruited from the following:

* Individuals identified through the SPORE Tissue Procurement Screening Project with moderate or severe dysplasia.
* Patients identified by private and academic physicians with moderate or severe dysplasia on cytology.
* One year or greater survivors of one or more aerodigestive system carcinomas.
* Patients with head and neck cancers who are undergoing routine panendoscopy.
* Patients undergoing resection of a bronchogenic carcinoma.
* Fully resected Stage I non-small cell cancer patients.
* Patient's undergoing bronchoscopy for diagnosis or staging of suspected lung cancer.
* Subjects with previous high-grade dysplasia or worse undergoing subsequent bronchoscopy for surveillance or monitoring of response to endobronchial treatment.
* 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.

Exclusion Criteria:

Patients are not eligible if any one of the following conditions exist:

* Clinically apparent bleeding diathesis.
* Cardiac dysrhythmia that is potentially life threatening, such as ventricular tachycardia, multifocal premature ventricular contractions or supraventricular tachycardias with a rapid ventricular response. Well-controlled atrial fibrillation or rare (\< 2/minute) premature ventricular contractions are not exclusionary.
* Hypoxemia (less than 90% saturation with supplemental oxygen) prior to bronchoscopy.
* Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, anginal chest pain, or poorly controlled congestive heart failure, or any other serious medical condition which would preclude a patient from undergoing a bronchoscopy.
* Acute bronchitis or pneumonia within 8 weeks, except if these are considered clinically to be possibly a result of lung cancer.
* Inability to give informed consent

Where it's running

• University of Colorado Cancer Center at UC Health Sciences Center
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Robert L. Keith, MD — University of Colorado Cancer Center, Anschutz Medical Campus; Rocky Mountain Regional VA Medical Center
• Study coordinator: Brandi Kubala, MA, CCRP
• Email: brandi.kubala@cuanschutz.edu
• Phone: 303-724-1657

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.