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

National Institutes of Health (NIH)

Status: Terminated

Conditions: Head and Neck Carcinoma

Study type: Observational

Funder types: NIH

Identifiers

NCT04618432

000077-DC

10000077

Details and patient eligibility

About

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

Full 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

Enrollment: 26 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

26 participants in 1 patient group

Patients

Description:

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