Head and Neck CarcinomaNCT04618432
Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
An observational study of Head and Neck Carcinoma, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial summary
Study Description: It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Head and Neck Carcinoma
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2020to 7 Jun 2023
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers
Who may be able to join
- Patients must be age 2 years or older if procedures or treatment are required.
- Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder.
- An NIDCD clinical investigator and PI determines it is in the interest of the patient/individual and NIDCD CRP for the subject to undergo consult, treatment or follow-up at the NIDCD/NIH
- Patient or their Legally Authorized Representative is able to provide informed consent.
Who cannot join
- Candidates who do not meet the inclusion criteria.
- Candidates who in the opinion of the PI and clinical team have medical or unstable conditions for which NIDCD and CC consultative services are unable to provide or support optimal care
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Study Description:
It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with head and neck and communication disorders by the NIDCD CRP, Clinical Center, and consult services. No investigational therapies will be administered in this
Read more
study.
Objectives and Endpoints:
(Summation)To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders
(Summation)To evaluate patients to determine candidacy for intramural clinical studies
Study Population:
Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers
Description of Sites:
NIH Clinical Center
Study Duration:
10 years
Read the detailed description
Study Description:
It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with head and neck and communication disorders by the NIDCD CRP, Clinical Center, and consult services. No investigational therapies will be administered in this
study.
Objectives and Endpoints:
(Summation)To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders
(Summation)To evaluate patients to determine candidacy for intramural clinical studies
Study Population:
Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers
Description of Sites:
NIH Clinical Center
Study Duration:
10 years
- Conditions
- Head and Neck Carcinoma
- Keywords
- Carcinoma, Hearing, Balance, Neoplasm, Natural History
- Medical subject headings
- Carcinoma, Neoplasms
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 |
|---|---|---|
| Patients | Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation for clinical studies
To evaluate patients to determine candidacy for intramural clinical studies
Measured: ongoing
Clinical data collection
To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start3 Nov 2020
- Primary completion7 Jun 2023
- Study completion7 Jun 2023
Why it stopped: PI moved institutes in NIH, and this protocol was redundant with an existing clinical protocol within the new institute.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies 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
- 26 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
- Clint T Allen, M.D., Principal investigator, National Institute on Deafness and Other Communication Disorders (NIDCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618432
- Sponsor's protocol ID
- 10000077
- Other IDs
- 000077-DC
- Status last verified
- Jun 2023
- First submitted
- 5 Nov 2020
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
- ClinicalTrials.gov ID
- NCT04618432
- Acronym / sponsor ID
- 10000077
- Conditions
- Head and Neck Carcinoma
- Keywords
- Carcinoma, Hearing, Balance, Neoplasm, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI moved institutes in NIH, and this protocol was redundant with an existing clinical protocol within the new institute.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 7 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 6 Nov 2020 (actual)
- 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.
Study Description:
It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with head and neck and communication disorders by the NIDCD CRP, Clinical Center, and consult services. No investigational therapies will be administered in this
study.
Objectives and Endpoints:
(Summation)To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders
(Summation)To evaluate patients to determine candidacy for intramural clinical studies
Study Population:
Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers
Description of Sites:
NIH Clinical Center
Study Duration:
10 years
Detailed description
Study Description:
It may be in the interest of the NIDCD Clinical Research Program (CRP) to collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders and to evaluate patients to determine candidacy for intramural clinical studies. This protocol will provide the administrative vehicle to enable the evaluation and provision of clinical care for patients with head and neck and communication disorders by the NIDCD CRP, Clinical Center, and consult services. No investigational therapies will be administered in this
study.
Objectives and Endpoints:
(Summation)To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders
(Summation)To evaluate patients to determine candidacy for intramural clinical studies
Study Population:
Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers
Description of Sites:
NIH Clinical Center
Study Duration:
10 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder referred to NIDCD Clinical Investigators by the Intramural Consult Service or community providers
Key inclusion criteria (4 listed)
- Patients must be age 2 years or older if procedures or treatment are required.
- Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder.
- An NIDCD clinical investigator and PI determines it is in the interest of the patient/individual and NIDCD CRP for the subject to undergo consult, treatment or follow-up at the NIDCD/NIH
- Patient or their Legally Authorized Representative is able to provide informed consent.
Key exclusion criteria (2 listed)
- Candidates who do not meet the inclusion criteria.
- Candidates who in the opinion of the PI and clinical team have medical or unstable conditions for which NIDCD and CC consultative services are unable to provide or support optimal care
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
Evaluation for clinical studies
Time frame: ongoing
To evaluate patients to determine candidacy for intramural clinical studies
Clinical data collection
Time frame: ongoing
To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders
Results and safety
The study was stopped early (reason given: PI moved institutes in NIH, and this protocol was redundant with an existing clinical protocol within the new institute.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- 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.
Clint T Allen, 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 Carcinoma, 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 4 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 13 Jun 2023. 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: PI moved institutes in NIH, and this protocol was redundant with an existing clinical protocol within the new institute.). 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?
Evaluation for clinical studies (time frame: ongoing). The study lists 2 primary outcomes in all. 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 13 Jun 2023.