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

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)

Overall Status

Recruiting

CT.gov ID

NCT04618432

Collaborator

(none)

300

Enrollment

Location

121.9

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Head and Neck Carcinoma

Detailed Description

Study Description:

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:

Description of Sites:

NIH Clinical Center

Study Duration:

10 years

Study Design

Study Type:

Observational

Anticipated 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 :

Nov 3, 2020

Anticipated Primary Completion Date :

Jul 31, 2030

Anticipated Study Completion Date :

Dec 31, 2030

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Evaluation for clinical studies [ongoing]
To evaluate patients to determine candidacy for intramural clinical studies
Clinical data collection [ongoing]
To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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