NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study ID
NCT06303180
Status
Recruiting

Conditions

  • Head and Neck Neoplasms
  • Hearing Disorders
  • Hearing Loss
  • Laryngeal Disease

Eligibility Criteria

Sex
ALL
Age
3 Years - 99 Years
Healthy Volunteers
Not accepted

Study Details

Background: Many disorders of the head and neck can affect a person s hearing; balance; smell; taste; swallowing; voice; or speech. These disorders include cancers and genetic and inflammatory diseases. To find better ways to diagnose and treat these disorders, researchers need to study tissues and other biological samples from people who have them. Objective: To collect biological samples for a repository that will be used for research. Eligibility: People of any age with a disorder of the head and neck that requires the taking of biological samples. The conditions may be any that affect hearing; balance; smell; taste; swallowing; voice; or speech. Design: Part 1: Participants will give permission for their leftover tissue samples to be used for research. These are tissue samples from the head and neck that were collected in the course of routine tests and care or other research studies. Information on each participant s age, diagnosis, and previous treatments will also be collected. Part 2: Some participants may be asked for more samples. All those aged 3 years or older will have a physical exam. They will provide blood and saliva samples. A cotton swab or brush will be used to collect cells from the inside of the cheek. Participants 18 years or older may have additional tests. They may provide nasal secretions: A piece of gelfoam or a sponge will be placed in the nose to soak up secretions for 5 to 10 minutes. They may have biopsies: Small samples of tissue will be cut from the skin and the tissue lining the mouth. Samples may be used for genetic testing.

Key Dates

Start date
Mar 4, 2024
Status verified
Nov 2025
Primary completion
Dec 30, 2033
Completion
Dec 30, 2033

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 1
    Patients with head and neck conditions affecting hearing, balance, smell, taste, swallowing, voice and speech.

Primary Outcome Measure

To create a biorepository of diseased and normal tissue specimens for research purposes. [ Time Frame: Ongoing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
Marcia Mulquin, RN, MSN
301-496-1601
NIH Clinical Center Office of Patient Recruitment (OPR)
(800) 411-1222

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