COPD, HEAD&NECK CANCER,SCREENINGNCT02333812
Prevalence of Malignant and Premalignant Lesions in the Head & Neck in Patients With Chronic Obstructive Pulmonary Disease
An observational study of COPD, HEAD&NECK CANCER,SCREENING, run by Hadassah Medical Organization.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- COPD, HEAD&NECK CANCER,SCREENING
- What is being tested?
- Stroboscopic nasopharyngeal laryngoscopy
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- group of adult COPD patients.
- 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, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine
Who cannot join
- Patients with an acute disease or COPD exacerbation
- Pregnant patients
- Patients who were intubated ≤3 months prior to inclusion
- Patients with a medical history of surgical intervention in the upper airway
- Patients with a medical history of malignant disease in the upper airway
- Patients who underwent radiotherapy of head and neck
Trial locations and contacts
No sites are listed yet.
Tali Zemer- Landau contact
About this study
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.
- Conditions
- COPD, HEAD&NECK CANCER,SCREENING
- Being tested
- Stroboscopic nasopharyngeal laryngoscopy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroboscopic nasopharyngeal laryngoscopyOther
Stroboscopic nasopharyngeal laryngoscopyOther
Stroboscopic nasopharyngeal laryngoscopyOther
| Study group | Role | What they receive |
|---|---|---|
| copd patients | Adult patients with COPD Receives: 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. Receives: Other: Stroboscopic nasopharyngeal laryngoscopy | |
| Adult patients with lung disease unrelated to smoking | Adult patients with lung disease unrelated to smoking Receives: Other: Stroboscopic nasopharyngeal laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of hospital stay, an expected average of one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD, HEAD&NECK CANCER,SCREENINGStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333812
- Sponsor's protocol ID
- 0318-14-HMO-CTIL
- Status last verified
- Sep 2014
- First submitted
- 17 Sep 2014
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Malignant and Premalignant Lesions in the Head & Neck in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02333812
- Acronym / sponsor ID
- 0318-14-HMO-CTIL
- Conditions
- COPD, HEAD&NECK CANCER,SCREENING
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| copd patients | – | Other: Stroboscopic nasopharyngeal laryngoscopyAdult patients with COPD |
| healthy smokers | – | Other: Stroboscopic nasopharyngeal laryngoscopyAdult 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 | – | Other: Stroboscopic nasopharyngeal laryngoscopyAdult patients with lung disease unrelated to smoking |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- group of adult COPD patients.
- 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, i.e. bronchial asthma who will be recruited from the institute of pulmonary medicine
Key exclusion criteria (6 listed)
- Patients with an acute disease or COPD exacerbation
- Pregnant patients
- Patients who were intubated ≤3 months prior to inclusion
- Patients with a medical history of surgical intervention in the upper airway
- Patients with a medical history of malignant disease in the upper airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroboscopic nasopharyngeal laryngoscopy | Other | copd patients |
| Stroboscopic nasopharyngeal laryngoscopy | Other | healthy smokers |
| Stroboscopic nasopharyngeal laryngoscopy | Other | Adult patients with lung disease unrelated to smoking |
Primary outcome
the primary outcome measure is the number of patients with malignant tumors and pre-malignant lesions of the head & neck
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tali Zemer- Landau contact
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, HEAD&NECK CANCER,SCREENING, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tali Zemer- Landau (LANDAUT@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the primary outcome measure is the number of patients with malignant tumors and pre-malignant lesions of the head & neck (time frame: participants will be followed for the duration of hospital stay, an expected average of one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2015.