Clinical trial NCT04618432: Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
Official title: Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Carcinoma
Keywords: Carcinoma
Hearing
Balance
Neoplasm
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-11-06
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

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

Eligibility 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

Primary outcomes:
measure: Evaluation for clinical studies
timeFrame: ongoing
measure: Clinical data collection
timeFrame: ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Clint T Allen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: