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Patient Evaluation for Head and Neck Surgery Branch Studies

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ClinicalTrials.gov Identifier: NCT00011492
Recruitment Status : Recruiting
First Posted : February 23, 2001
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) )

Tracking Information
First Submitted Date February 22, 2001
First Posted Date February 23, 2001
Last Update Posted Date September 16, 2019
Actual Study Start Date August 16, 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: October 17, 2018)
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. [ Time Frame: 12/31/2020 ]
To evaluate patients to meet the eligibility criteria of active NIDCD HNSB or other IC Head and Neck protocols
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00011492 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 17, 2018)
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 [ Time Frame: 12/31/20 ]
To provide expertise clinical care during screening and surgical procedures and training of ENT and other Physicians and Clinical Associates in the care and surgical procedures needed for head and neck subjects and the development of new head and neck surgery and treatment protocols and procedures, along with new ideas for clinical HN research
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects with Head and Neck Disorders including Cancer will be screened under this protocol. Subjects can be from any location, ages 4-99 in age, any gender, race, and ethnicity. Subjects can self refer or come from another protocol or physician's office.@@@
Condition
  • Head and Neck Neoplasms
  • Pharyngeal Cancer
  • Oral Cancer
  • Carcinoma, Squamous Cell
  • Laryngeal Cancer
Intervention Not Provided
Study Groups/Cohorts 1
a single cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 23, 2005)
300
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Marcia L Mulquin, R.N. (240) 858-3752 mmulquin@mail.nih.gov
Contact: Carter Van Waes, M.D. (301) 402-4216 vanwaesc@nidcd.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00011492
Other Study ID Numbers 010099
01-DC-0099
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) )
Study Sponsor National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborators Not Provided
Investigators
Principal Investigator: Carter Van Waes, M.D. National Institute on Deafness and Other Communication Disorders (NIDCD)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 14, 2019