Clinical trial · Observational
Biomarkers in the Nose, Throat, and Lung Tissue of Smokers and Non-Smokers
Analysis of Intermediate Endpoint Biomarkers in the Respiratory Epithelium of Smokers Compared to Non-Smoking Controls
NCT00897364CI-TRIAL-00045113completedClinicalTrials.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 tissue from smokers and non-smokers in the laboratory may help doctors identify and learn more about biomarkers related to cancer. PURPOSE: This phase II study is looking at biomarkers in the nose, throat, and lung tissue of smokers and non-smokers.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Molecular and biochemical profiles
- timeFrame
- Upon completion of trial
- description
- Evaluation of both Molecular and Biochemical profiles of normal non-smokers, smokers with no apparent disease (no airflow obstruction or cancer), and smokers with airflow obstruction and abnormal sputum cytology.
Secondary outcomes (1)
- measure
- Occurrence of abnormalities
- timeFrame
- Upon completion of trial
- description
- Stratify abnormalities as to whether they occur frequently in normal non-smokers, smokers without disease, smokers with various grades of dysplasia, or smokers with lung cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. \- Adults \> 45 years of age, to be age matched with a previously enrolled cohort of current and ex-smokers with airflow obstruction and moderate atypia on sputum cytology, to be included in the following groups. 2. \- Non-smoking (less than 100 cigarettes per lifetime) controls \>50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction (FEV1 \< 75% predicted and FEV1/FVC \< 75%) and moderate atypia on sputum cytology. 3. \- Current smokers with \> 30 pack years, no airflow obstruction (FEV1 \> 90% predicted) or lung cancer, \>50 years of age, to be age matched with a previously enrolled cohort with airflow obstruction and moderate atypia on sputum cytology . 4. \- No prior history of a head and neck or bronchogenic carcinoma. 5. \- Patients must be fully informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and FDA guidelines. Exclusion Criteria: 1. \- Clinically apparent bleeding diathesis. 2. \- 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. 3. \- Hypoxemia (less than 90% saturation with supplemental oxygen) during bronchoscopy. 4. \- Evidence of clinically active coronary artery disease, including myocardial infarction within 6 weeks, chest pain, or poorly controlled congestive heart failure, or any other serious medical condition which would preclude a patient from undergoing a bronchoscopy. 5. \- Acute bronchitis or pneumonia within 8 weeks. 6. \- Inability to give informed consent. 7. \- Current smokers with no airflow obstruction may not have a history of coughing more than two times /week.
References
Publications (0)
Data not yet available
No reference posted for this study.