Characterization of Head and Neck Malignant Tumors Using an Electronic Nose

NCT01816919 | Completed DMC

• 1 other identifier: CMC-09-0075-CTIL
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Head and neck tumors are common in the general population especially in high risk groups of smokers and alcohol abusers, as well as after exposure to various environmental factors. Diagnosis is based on identification of patients gross disease after a physical examination and various imaging methods, and characterization of tissue mainly by fine-needle puncture (FNA) and biopsy. Determining the stage of disease is based on physical examination, imaging and tissue samples. Using the electronic nose technology we hope to identify microscopic disease when it is suspected or in populations in risk, thus diagnose patients in the initial stages of the disease. Obviously, early diagnosis and treatment decisions will hopefully improve the prognosis. Finding a positive correlation between the stages, levels and various tumor volume and respiratory specimens findings will classify patients more accurately and contribute to further characterization of the disease in a more accurate, rapid and non-invasive fashion.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Characterization of biochemical markers in breath samples of patients with head and neck cancer by using artificial olfactory system (electronic nose).

  one year

Study Arms (1)

eNose breath samples

EXPERIMENTAL

Other: collecting breath samples

Interventions

collecting breath samples OTHER

eNose breath samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with head and neck tumors
• A patient can understand, read and sign the informed consent form, signing a consent form
• Age over 18

You may not qualify if:

• Known or second primary head and neck cancer
• Surgery to head and neck index tumor except for tumor biopsy
• Unsteady comorbidity
• Pregnancy
• breastfeeding

Sponsors & Collaborators

• Carmel Medical Center: lead
• Technion, Israel Institute of Technology: collaborator

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: November 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 31, 2015

Record last verified: 2013-03