Patient Evaluation for Head and Neck Surgery Branch Studies

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Brief Title

Patient Evaluation for Head and Neck Surgery Branch Studies

Official Title

Evaluation for NIDCD Head & Neck Surgery Branch Clinical Research Protocols

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.
    

Detailed 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.
    


Study Type

Observational


Primary Outcome

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.

Secondary Outcome

 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

Condition

Head and Neck Neoplasms


Study Arms / Comparison Groups

 1/All Patients
Description:  All eligible patients

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

62

Start Date

March 12, 2001

Completion Date

November 23, 2020

Primary Completion Date

November 23, 2020

Eligibility Criteria

        -  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 and not eligible.

        Candidates who do not meet the inclusion criteria.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Carter Van Waes, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00011492

Organization ID

010099

Secondary IDs

01-DC-0099

Responsible Party

Sponsor

Study Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)


Study Sponsor

Carter Van Waes, M.D., Principal Investigator, National Institute on Deafness and Other Communication Disorders (NIDCD)


Verification Date

August 2020