Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT00011492 |
Other study ID # |
010099 |
Secondary ID |
01-DC-0099 |
Status |
Terminated |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 12, 2001 |
Est. completion date |
November 23, 2020 |
Study information
Verified date |
August 2020 |
Source |
National Institutes of Health Clinical Center (CC) |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
This protocol will provide a means for screening potential candidates for NIDCD Head and Neck
Surgery Branch (HNSB), and inter-institute protocols with NCI and NIDCR. No investigational
treatments will be administered on this protocol. The Principal Investigator may, however,
approve a patient who has been determined to be ineligible for investigational protocols to
undergo standard treatment because they present a unique clinical experience for maintaining
clinical skills of HNSB physicians and training of clinical fellows.
Background:
Potential research candidates are referred to the NIDCD HNSB by physicians and by patients
themselves. Up to half of all research subjects now admitted to NIH protocols are
self-referred. Each patient undergoes thorough telephone screening including a request for
the results of outside laboratory tests, scans, x-rays and protocols. Some protocols may
require additional diagnostic tests or that tests be repeated to obtain more current results
in an effort to establish eligibility according to protocol specifications. The purpose of
this protocol is to provide a means for patients to undergo: (1) evaluation to meet the
eligibility requirements of active NIDCD HNSB and inter-institute protocols; and (2) standard
treatment to ensure adequate expertise and training of surgeons and clinical associates and
to provide an environment that stimulates ideas for clinical research.
Objectives:
-To permit evaluation of patients referred to the NIDCD Head and Neck Surgery Branch
(HNSB) in order to identify individuals who will be suitable candidates for HNSB
clinical research protocols and inter-institute protocols with NCI and NIDCR.
-To permit standard treatment in specific circumstances for patients not eligible for a
current investigational protocol, but who present a unique clinical training opportunity or
who present a clinical condition during screening that requires immediate intervention to
prevent compromise to the patient s well-being.
Eligibility:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Women who are pregnant are not eligible
- Candidates who do not meet the inclusion criteria.
Design:
-Patients enrolled on this protocol will be evaluated by NIDCD HNSB physicians to
determine the individual s suitability for participation in a clinical research protocol.
Specific clinical pathology and research diagnostic tests may be required to meet the
eligibility criteria of a protocol. These may include, but are not limited to:
- Blood tests
- Computerized Tomography scans without or with contrast
- Magnetic Resonance Imaging without or with gadolinium contrast
- Positron Emission Tomography
- Arterio- or Angiogram
- Nuclear Medicine scans (e.g. Technecium, Gallium)
- Pulmonary Function Tests
- Endoscopy of upper aerodigestive tract
- Fine needle aspiration or Tissue Biopsy
Other tests that are clinically indicated may be performed.
Other known NCT identifiers