Patient Evaluation for Head and Neck Surgery Branch Studies

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00011492
First received: February 22, 2001
Last updated: March 22, 2014
Last verified: March 2014
  Purpose

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.


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

Study Type: Observational
Official Title: Evaluation for NIDCD Head & Neck Surgery Branch Clinical Research Protocols

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 300
Study Start Date: February 2001
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.

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00011492

Contacts
Contact: Susannah S Wargo, C.R.N.P. (301) 496-4887 swargo@mail.nih.gov
Contact: Carter Van Waes, M.D. (301) 402-4216 vanwaesc@nidcd.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Carter Van Waes, M.D. National Institute on Deafness and Other Communication Disorders (NIDCD)
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00011492     History of Changes
Obsolete Identifiers: NCT00045071
Other Study ID Numbers: 010099, 01-DC-0099
Study First Received: February 22, 2001
Last Updated: March 22, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Oral Cancer
Squamous Cell Carcinoma
Head and Neck Cancer
Laryngeal Cancer
Pharnygeal Cancer

Additional relevant MeSH terms:
Carcinoma
Laryngeal Neoplasms
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Mouth Neoplasms
Lip Neoplasms
Pharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Otorhinolaryngologic Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Neoplasms, Squamous Cell
Mouth Diseases
Stomatognathic Diseases
Lip Diseases
Pharyngeal Diseases

ClinicalTrials.gov processed this record on August 20, 2014