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Status unknownNCT02333812Updated Jan 7, 2015

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

An observational study in COPD, HEAD&NECK CANCER,SCREENING, sponsored by Hadassah Medical Organization. Status unknown. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-01-07.

Sponsored by Hadassah Medical Organization · Observational

The sponsor has not verified this record recently (last verified Sep 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
250
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • COPD, HEAD&NECK CANCER,SCREENING
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In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 250 is above the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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:

  1. 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.
  1. Adult patients with lung disease unrelated to smoking, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine

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

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

    Adult patients with lung disease unrelated to smoking

    Other: Stroboscopic nasopharyngeal laryngoscopy

Interventions

  • OtherStroboscopic nasopharyngeal laryngoscopy
  • OtherStroboscopic nasopharyngeal laryngoscopy
  • OtherStroboscopic nasopharyngeal laryngoscopy
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: participants will be followed for the duration of hospital stay, an expected average of one week

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02333812
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
Jan 7, 2015
Start date
Jan 2015
Primary completion
Dec 2015 (estimated)
Last update
Jan 7, 2015

Study contacts

Tali Zemer- Landau
Contact
LANDAUT@clalit.org.il

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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