Patient Evaluation for Head and Neck Surgery Branch Studies

NCT00011492 | Terminated

• 2 other identifiers: 01009901-DC-0099
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Neoplasms; Pharyngeal Cancer; Oral Cancer; Carcinoma, Squamous Cell; Laryngeal Cancer

Keywords

Oral Cancer; Squamous Cell Cancer; Head and Neck Cancer; Laryngeal Cancer; Pharnygeal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  To evaluate patients to meet the eligibility criteria of active NIDCD HNSB or other IC Head and Neck protocols

  12/31/2021

Secondary Outcomes (1)

• 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

  12/31/2021

Study Arms (1)

1/All Patients

All eligible patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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, age 4 - no maximum age, any gender, race, and ethnicity. Subjects can selfrefer or come from another protocol or physician's office.

You may qualify if:

• 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.

You may not qualify if:

• Women who are pregnant and not eligible.

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Head and Neck Neoplasms; Pharyngeal Neoplasms; Mouth Neoplasms; Carcinoma, Squamous Cell; Laryngeal Neoplasms; Neoplasms, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Study Officials

• Carter Van Waes, M.D.

  National Institute on Deafness and Other Communication Disorders (NIDCD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2001
• First Posted: February 23, 2001
• Study Start: March 12, 2001
• Primary Completion: November 23, 2020
• Study Completion: November 23, 2020
• Last Updated: November 27, 2020

Record last verified: 2020-08

Locations

US (1)