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Biomarker Study for Respiratory Tract Dysplasia or Cancer

This observational study is looking at biomarkers (biological signs) in people with dysplasia (abnormal cell growth) in the respiratory tract, or with lung, head and neck, or aerodigestive tract cancer. Researchers will collect samples like sputum (mucus from the lungs) and tissue through procedures like biopsies (removing small tissue samples) and analyze them using laboratory tests such as immunohistochemistry staining and other biomarker analyses. The main goal is to find genetic changes or altered growth factor expression that could be important for understanding these conditions. This study aims to enroll 700 participants aged 21 to 90 years old, including those with severe dysplasia or those who have survived certain aerodigestive system cancers.

Study design
This is an observational study planning to enroll 700 participants. It is not a treatment study but rather collects and analyzes samples.
What's involved
You would undergo sputum cytology, bronchoscopy (a procedure to look inside the airways), and biopsies. You would also have endobronchial brushings and bronchial secretion collection, and possibly bronchoalveolar lavage (washing out the airways).
Compensation
Not stated in the trial record.
Follow-up
Genetic mutations or altered growth factor expression will be measured after the study has completed.

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NCT00900419

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

Recruiting
Not specifiedAges 21–90Observational
University of Colorado, Denver
~700 participants
Updated 2025-09-22 on ClinicalTrials.gov
What's tested:immunohistochemistry staining methodlaboratory biomarker analysissputum cytologybiopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Genetic mutations or altered growth factor expression
Measured over After study has completed

Conditions

Esophageal Cancer
Head and Neck Cancer
Lung Cancer
Precancerous Condition

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Where it's being run

1 sites across 1 states
Colorado1

Study leadership

  • York E. Miller, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver

Who to contact

Brandi Kubala
[email protected]
303-724-1657
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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
See Disease Characteristics

What this trial measures

  • Genetic mutations or altered growth factor expressionAfter study has completed