NCT00900419 Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
| NCT ID | NCT00900419 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Esophageal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 700 participants |
| Start Date | 2001-05-03 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 700 participants in total. It began in 2001-05-03 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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. * 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
Contact & Investigator
York E. Miller, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT00900419 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 90 Years, studying Esophageal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00900419 currently recruiting?
Yes, NCT00900419 is actively recruiting participants. Contact the research team at brandi.kubala@cuanschutz.edu for enrollment information.
Where is the NCT00900419 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT00900419 clinical trial?
NCT00900419 is sponsored by University of Colorado, Denver. The principal investigator is York E. Miller, MD at University of Colorado, Denver. The trial plans to enroll 700 participants.
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