Clinical trial · Observational
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Biomarkers and Dysplastic Respiratory Epithelium
NCT00900419CI-TRIAL-00095526recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| sputum cytology | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Genetic mutations or altered growth factor expression
- timeFrame
- After study has completed
Secondary outcomes (1)
- measure
- Establishment of a tissue repository of normal and dysplastic respiratory epithelium
- timeFrame
- After study has closed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.