Working… Menu

Patient Evaluation for Head and Neck Surgery Branch Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00011492
Recruitment Status : Terminated (Closed by Sponsor/Data Safety monitoring Board/IRB)
First Posted : February 23, 2001
Last Update Posted : November 27, 2020
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) )

Brief Summary:

This purpose of this protocol is to evaluate and identify patients who may be eligible for actively enrolling NIH clinical research protocols for head and neck cancer; or provide standard evaluations and treatment necessary for patients with head and neck cancers enrolled in other NIH clinical protocols that do not include such treatment. Participants screened under this protocol will not be required to join a research study; the decision will be voluntary.

Patients with head and neck cancer may enroll in this study. Participants may undergo various tests, described below, to determine their eligibility for participation in a specific clinical trial. Other tests may also be required, depending on the protocol or treatment for which the patient is being considered:

  • Blood tests About 3 to 5 tablespoons of blood will be drawn for routine tests, HLA typing and hepatitis and HIV screening.
  • Magnetic resonance imaging (MRI) This imaging procedure uses a powerful magnetic field to produce pictures of parts of the body in small section views. The test does not use radiation and may be done with or without a contrast dye material.
  • Computerized tomography (CT) This procedure uses x-rays to produces three-dimensional images of body organs in small section views. A contrast dye may or may not be used.
  • Positron emission tomography (PET) PET scans allow the doctor to see the activity of cells in specific body tissues. It requires injection of a radioactive material that attaches to a sugar fluid. The fluid goes to very active cells, such as cancer cells, revealing tumors.
  • Pulmonary function tests These tests use a machine the patient breathes into to measure the volume of air the patient can move in and out of the lungs.
  • Arteriogram, or angiogram The anatomy of the blood vessels can be seen using this procedure, which involves placing a small catheter (plastic tube) into an artery and injecting a contrast solution. Special X-rays are then taken to show the blood vessels.
  • Endoscopy This procedure is done to evaluate the mouth and throat. A tube with a light on the end and special fibers is inserted down the throat to allow the surgeon to examine the throat and, if needed, biopsy a piece of tissue for microscopic study. The test is usually done under general anesthesia in the operating room.
  • Biopsy A piece of tissue or tumor is removed for examination under the microscope. When a biopsy is done in the neck area, a small amount of anesthetic is injected into the area of the biopsy. The biopsy may be done with 1) a small needle to pull out some tissue, 2) a cookie-cutter-like instrument to punch out a small piece of tissue, or 3) a small knife to cut out a piece of tissue. A knife biopsy may be done in the operating room or the clinic depending on the location of the biopsy and precautions required.

When the tests are done, the physician will discuss the results with the patient. Patients eligible for a research study will be offered participation. For those not eligible for a study, other therapies will be discussed and the patient will return to the care of his or her primary physician. In special circumstances, patients may be offered standard non-experimental treatment at NIH.

Condition or disease
Head and Neck Neoplasms Pharyngeal Cancer Oral Cancer Carcinoma, Squamous Cell Laryngeal Cancer

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation for NIDCD Head & Neck Surgery Branch Clinical Research Protocols
Actual Study Start Date : March 12, 2001
Actual Primary Completion Date : November 23, 2020
Actual Study Completion Date : November 23, 2020

1/All Patients
All eligible patients

Primary Outcome Measures :
  1. To permit evaluation of patients to NIDCD Head and Neck Branch in order to identify suitable candidates for NIDCD NCI Head and Neck protocols or other NCI-based Head and Neck Cancer protocols. [ Time Frame: 12/31/2021 ]
    To evaluate patients to meet the eligibility criteria of active NIDCD HNSB or other IC Head and Neck protocols

Secondary Outcome Measures :
  1. Evaluation of standard care treatment for subjects with head and neck disorders, train ENT surgeons and clinical associates in surgical intervention procedures and stimulate new ideas for clinical research [ Time Frame: 12/31/2021 ]
    To provide expertise clinical care during screening and surgical procedures and training of ENT and other Physicians and Clinical Associates in the care and surgical procedures needed for head and neck subjects and the development of new head and neck surgery and treatment protocols and procedures, along with new ideas for clinical HN research

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with Head and Neck Disorders including Cancer will be screened under this protocol. Subjects can be from any location, age 4 - no maximum age, any gender, race, and ethnicity. Subjects can selfrefer or come from another protocol or physician's office.

Age 18 and older

Patients at risk. Suspected of having, or with a biopsy proven neoplastic disease of the head and neck.

Patient is able to provide informed consent.


Women who are pregnant and not eligible.

Candidates who do not meet the inclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00011492

Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Layout table for investigator information
Principal Investigator: Carter Van Waes, M.D. National Institute on Deafness and Other Communication Disorders (NIDCD)
Additional Information:
Layout table for additonal information
Responsible Party: National Institute on Deafness and Other Communication Disorders (NIDCD) Identifier: NCT00011492    
Obsolete Identifiers: NCT00045071
Other Study ID Numbers: 010099
First Posted: February 23, 2001    Key Record Dates
Last Update Posted: November 27, 2020
Last Verified: August 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) ):
Oral Cancer
Squamous Cell Cancer
Head and Neck Cancer
Laryngeal Cancer
Pharnygeal Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Mouth Neoplasms
Laryngeal Neoplasms
Carcinoma, Squamous Cell
Pharyngeal Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Otorhinolaryngologic Neoplasms
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Pharyngeal Diseases