Head and Neck NeoplasmsNCT00011492
Patient Evaluation for Head and Neck Surgery Branch Studies
An observational study of Head and Neck Neoplasms and Pharyngeal Cancer, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Pharyngeal Cancer, Oral Cancer
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2001to 23 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Women who are pregnant and not eligible.
- Candidates who do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation for NIDCD Head & Neck Surgery Branch Clinical Research Protocols
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:
Read more
- 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.
Read the 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 (e.g. 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.
- 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
- Medical subject headings
- Head and Neck Neoplasms, Pharyngeal Neoplasms, Mouth Neoplasms, Carcinoma, Squamous Cell, Laryngeal Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/All Patients | All eligible patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 12/31/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2001 (estimated)
- Study start12 Mar 2001
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Why it stopped: Closed by Sponsor/Data Safety monitoring Board/IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Carter Van Waes, M.D., Principal investigator, National Institute on Deafness and Other Communication Disorders (NIDCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00011492
- Sponsor's protocol ID
- 010099
- Other IDs
- 01-DC-0099
- Status last verified
- Aug 2020
- First submitted
- 22 Feb 2001
- Last updated
- 27 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation for NIDCD Head & Neck Surgery Branch Clinical Research Protocols
- ClinicalTrials.gov ID
- NCT00011492
- Acronym / sponsor ID
- 010099
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Closed by Sponsor/Data Safety monitoring Board/IRB
- Enrolment
- 62 participants (actual)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 12 Mar 2001 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 23 Feb 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 (e.g. 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/All Patients | – | –All eligible patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Women who are pregnant and not eligible.
- Candidates who do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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: 12/31/2021
To evaluate patients to meet the eligibility criteria of active NIDCD HNSB or other IC Head and Neck protocols
1 secondary outcome
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: 12/31/2021
Results and safety
The study was stopped early (reason given: Closed by Sponsor/Data Safety monitoring Board/IRB). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carter Van Waes, M.D. principal investigator
National Institute on Deafness and Other Communication Disorders (NIDCD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Neoplasms and Pharyngeal Cancer, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Closed by Sponsor/Data Safety monitoring Board/IRB). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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: 12/31/2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.