Patient Evaluation for Head and Neck Surgery Branch Studies



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:4 - 99
Updated:1/31/2019
Start Date:August 16, 2004
Contact:Susannah S Wargo, C.R.N.P.
Email:swargo@mail.nih.gov
Phone:(301) 496-4887

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Evaluation for NIDCD Head & Neck Surgery Branch Clinical Research Protocols

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.

This protocol will provide a means for screening potential candidates for head and neck
surgery branch protocols. No investigational treatments will be administered in this
protocol. The PI may, however, approve a patient who has been determined to be ineligible for
HNSB protocols to undergo standard treatment because they present a unique clinical
experience for maintaining skills of HNSB physicians and clinical fellows.

- INCLUSION CRITERIA:

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

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

EXCLUSION CRITERIA:

Candidates who do not meet the inclusion criteria.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
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from
Bethesda, MD
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