Prevalence of Malignant and Premalignant Lesions in the Head & Neck in Patients With Chronic Obstructive Pulmonary Disease

• Conditions: COPD, HEAD&NECK CANCER,SCREENING
• Interventions: Other: Stroboscopic nasopharyngeal laryngoscopy

• Registration Number: NCT02333812
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Head and neck cancers usually occur in patients who have a history of long tobacco use. Chronic obstructive pulmonary disease (COPD) is a chronic progressive disease of the airways and lung parenchyma that is also associated with exposure to tobacco. COPD and head \& neck cancer share a common environmental risk factor in cigarette smoke exposure. the investigators hypothesize that patients with chronic lung disease related to smoking have a higher risk to develop cancer in the head and neck.

The investigators designed a study to assess the prevalence of cancer and pre-cancer disease in the head \& neck in patients with chronic lung disease. the investigators will examine patients with and without a history of smoking and chronic lung disease in order to determine the prevalence of head and neck cancer in the different groups. The patients who will be included in the study will undergo comprehensive evaluation of their lung function and voice performance.

This study is a joint effort of the Pulmonology Institute and the Department of Otolaryngology, Head \& Neck Surgery in Israel and the Netherlands.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-17
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-05
• Last Update Submitted: 2015-01-05
• Study First Posted: 2015-01-07
• Last Update Posted: 2015-01-07
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

1. group of adult COPD patients.
2. Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic.
3. Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine

Exclusion Criteria

1. Patients with an acute disease or COPD exacerbation
2. Pregnant patients
3. Patients who were intubated ≤3 months prior to inclusion
4. Patients with a medical history of surgical intervention in the upper airway
5. Patients with a medical history of malignant disease in the upper airway
6. Patients who underwent radiotherapy of head and neck

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy smokers	Stroboscopic nasopharyngeal laryngoscopy	Adult patients with smoking history and no clinical manifestation of COPD who will be recruited form the institute of pulmonary medicine and the otolaryngology outpatient clinic.
Adult patients with lung disease unrelated to smoking	Stroboscopic nasopharyngeal laryngoscopy	Adult patients with lung disease unrelated to smoking
copd patients	Stroboscopic nasopharyngeal laryngoscopy	Adult patients with COPD

Primary Outcome Measures

Name	Time	Method
the primary outcome measure is the number of patients with malignant tumors and pre-malignant lesions of the head & neck	participants will be followed for the duration of hospital stay, an expected average of one week	prevalence of malignant tumors and pre-malignant lesions of the head \& neck in general, and the larynx in particular, is significantly increased in the COPD patient population in comparison to patients with history of smoking without clinical presentation of COPD and patients with no history of smoking.