Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders

Study Overview
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Brief Summary
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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
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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

Official Title
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Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders

Conditions
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Head and Neck Carcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation for clinical studies | To evaluate patients to determine candidacy for intramural clinical studies | ongoing | 
| Clinical data collection | To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders | ongoing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carcinoma, Hearing, Balance, Neoplasm, Natural History