Prevalence of Malignant and Premalignant Lesions in the H... | NCT02333812

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

NCT02333812

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jan 7, 2015Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

COPD, HEAD&NECK CANCER,SCREENING

Interventions

Stroboscopic nasopharyngeal laryngoscopy
Stroboscopic nasopharyngeal laryngoscopy
Stroboscopic nasopharyngeal laryngoscopy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Sep 17, 2014

First Submission Date that Met QC Criteria

Jan 5, 2015

First Posted Date

Jan 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2015

Last Update Posted Date

Jan 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Stroboscopic nasopharyngeal laryngoscopy	Other		copd patients
Stroboscopic nasopharyngeal laryngoscopy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive
D006258	Head and Neck Neoplasms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009371	Neoplasms by Site
D009369	Neoplasms