- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04618432
Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
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 Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Clint T Allen, M.D.
- Phone Number: (301) 402-4216
- Email: clint.allen@nih.gov
Study Contact Backup
- Name: Marcia L Mulquin, R.N.
- Phone Number: (301) 496-1601
- Email: mmulquin@mail.nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Patients
Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation for clinical studies
Time Frame: ongoing
|
To evaluate patients to determine candidacy for intramural clinical studies
|
ongoing
|
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
|
ongoing
|
Collaborators and Investigators
Investigators
- Principal Investigator: Clint T Allen, M.D., National Institute on Deafness and Other Communication Disorders (NIDCD)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10000077
- 000077-DC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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