Clinical trial NCT02333812: Prevalence of Malignant and Premalignant Lesions in the Head & Neck in Patients With Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD, HEAD&NECK CANCER,SCREENING
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2015-01-07
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: the primary outcome measure is the number of patients with malignant tumors and pre-malignant lesions of the head & neck
timeFrame: participants will be followed for the duration of hospital stay, an expected average of one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: