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

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.

Study Overview

• Status: Unknown
• Conditions: COPD, HEAD&NECK CANCER,SCREENING
• Intervention / Treatment: Other: Stroboscopic nasopharyngeal laryngoscopy

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study group of adult COPD patients will be recruited from the Institute of Pulmonary medicine patient pool and referred for further evaluation in the Voice and Swallowing disorders outpatient Clinic in Hadassah University Medical Center.The study group will be compared to two control group:

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
copd patients; Adult patients with COPD	Other: Stroboscopic nasopharyngeal laryngoscopy
healthy smokers; 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.	Other: Stroboscopic nasopharyngeal laryngoscopy
Adult patients with lung disease unrelated to smoking	Other: Stroboscopic nasopharyngeal laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the primary outcome measure is the number of patients with malignant tumors and pre-malignant lesions of the head & neck	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.	participants will be followed for the duration of hospital stay, an expected average of one week

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: January 5, 2015
• First Posted (Estimate): January 7, 2015

Study Record Updates

• Last Update Posted (Estimate): January 7, 2015
• Last Update Submitted That Met QC Criteria: January 5, 2015
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 0318-14-HMO-CTIL