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

Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04618432
• Other study ID #: 10000077
• Secondary ID: 000077-DC
• Status: Terminated
• Start date: November 3, 2020
• Est. completion date: June 7, 2023

Study information

• Verified date: June 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Communication Disorders
• Head and Neck Carcinoma

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation for clinical studies	To evaluate patients to determine candidacy for intramural clinical studies	ongoing
Primary	Clinical data collection	To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders	ongoing

External Links

•   NIH Clinical Center Detailed Web Page