Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00011492
Status:
TERMINATED
Last Update Posted:
2020-11-27
First Post:
2001-02-22
Brief Title:
Patient Evaluation for Head and Neck Surgery Branch Studies
Sponsor:
National Institute on Deafness and Other Communication Disorders NIDCD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation for NIDCD Head Neck Surgery Branch Clinical Research Protocols
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed by SponsorData Safety monitoring BoardIRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-DC-0099 | None | None | None |