Patient Evaluation for Head and Neck Surgery Branch Studies
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| ClinicalTrials.gov Identifier: NCT00011492 |
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Recruitment Status :
Recruiting
First Posted : February 23, 2001
Last Update Posted : September 16, 2019
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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.
| Condition or disease |
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| Head and Neck Neoplasms Pharyngeal Cancer Oral Cancer Carcinoma, Squamous Cell Laryngeal Cancer |
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation for NIDCD Head & Neck Surgery Branch Clinical Research Protocols |
| Actual Study Start Date : | August 16, 2004 |
| Group/Cohort |
|---|
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1
a single cohort
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- 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
- 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
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 4 Years to 99 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00011492
| 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 |
| 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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov | |
| Principal Investigator: | Carter Van Waes, M.D. | National Institute on Deafness and Other Communication Disorders (NIDCD) |
Additional Information:
| Responsible Party: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
| ClinicalTrials.gov Identifier: | NCT00011492 History of Changes |
| Obsolete Identifiers: | NCT00045071 |
| Other Study ID Numbers: |
010099 01-DC-0099 |
| First Posted: | February 23, 2001 Key Record Dates |
| Last Update Posted: | September 16, 2019 |
| Last Verified: | May 14, 2019 |
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Oral Cancer Squamous Cell Cancer Head and Neck Cancer |
Laryngeal Cancer Pharnygeal Cancer Squamous Cell Carcinoma |
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Head and Neck Neoplasms Mouth Neoplasms Laryngeal Neoplasms Carcinoma, Squamous Cell Pharyngeal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms by Site |
Mouth Diseases Stomatognathic Diseases Otorhinolaryngologic Neoplasms Laryngeal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Otorhinolaryngologic Diseases Neoplasms, Squamous Cell Pharyngeal Diseases |