Protocol Number: 01-DC-0099

Title:

Evaluation for NIDCD Head & Neck Surgery Branch Clinical Research Protocols

Number:

01-DC-0099

Summary:

This protocol offers evaluation and, in some cases, standard treatment for patients with head and neck cancer in NIDCD's Head and Neck Surgery Branch (HNSB). The study is not designed to test new treatments. Its purpose is twofold: 1) to identify patients who may be eligible for investigational protocols. (Participants in this protocol will not be required to join a research study; the decision will be voluntary.); and 2) to provide standard treatment for patients who are not eligible for an investigational study but who present an education and training opportunity for HNSB physicians and clinical fellows.

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.

Sponsoring Institute:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA

Patients suspected of having or with a biopsy proven neoplastic disease of the head and neck are eligible.

Patient, parent or guardian (if a minor) able to provide informed consent.

EXCLUSION CRITERIA

Candidates who do not meet the inclusion criteria are not eligible.

Special Instructions: Currently Not Provided

Keywords:

Cancer

Squamous Cell Carcinoma

Recruitment Keywords:

Squamous Cell Carcinoma

Head and Neck Cancer

Conditions:

Head and Neck Cancer

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations: Not Provided

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Bethesda, Maryland 20892. Last update: 10/16/2004