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

NCT04618432 | Terminated

• 2 other identifiers: 10000077000077-DC
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Carcinoma

Keywords

Carcinoma; Hearing; Balance; Neoplasm; Natural History

Outcome Measures

Primary Outcomes (2)

• Evaluation for clinical studies

  To evaluate patients to determine candidacy for intramural clinical studies

  ongoing

• Clinical data collection

  To collect clinical data or specimens generated in the diagnosis and treatment of head and neck or communication disorders

  ongoing

Study Arms (1)

Patients

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

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Deafness and Other Communication Disorders (NIDCD): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Carcinoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Clint T Allen, M.D.

  National Institute on Deafness and Other Communication Disorders (NIDCD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: November 6, 2020
• Study Start: November 3, 2020
• Primary Completion: June 7, 2023
• Study Completion: June 7, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

US (1)