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

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ClinicalTrials.gov Identifier: NCT04618432
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : March 23, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) )

Brief 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. 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


Condition or disease
Head and Neck Carcinoma

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

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
Actual Study Start Date : November 3, 2020
Estimated Primary Completion Date : July 31, 2030
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
Patients at risk, suspected of having, have a history of, or currently have a diagnosed head and neck or communication disorder.



Primary Outcome Measures :
  1. Evaluation for clinical studies [ Time Frame: ongoing ]
    To evaluate patients to determine candidacy for intramural clinical studies

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04618432


Contacts
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Contact: Marcia L Mulquin, R.N. (301) 496-1601 mmulquin@mail.nih.gov
Contact: Clint T Allen, M.D. (301) 402-4216 clint.allen@nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Clint T Allen, M.D. National Institute on Deafness and Other Communication Disorders (NIDCD)
Additional Information:
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Responsible Party: National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier: NCT04618432    
Other Study ID Numbers: 10000077
000077-DC
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: January 30, 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) ):
Carcinoma
Hearing
Balance
Neoplasm
Natural History
Additional relevant MeSH terms:
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Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders