NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

This study is creating a collection of biological samples (like tissues, blood, and saliva) from people with head and neck disorders that affect hearing, balance, smell, taste, swallowing, voice, or speech. The goal is to build a resource for researchers to better understand these conditions and develop new ways to diagnose and treat them. You can join if you are between 3 and 99 years old and have a head and neck disorder that requires biological samples to be taken. The study aims to enroll 1000 participants and is currently ongoing.

Study design
This is an observational study, meaning researchers will collect samples and information without giving any specific treatments. It plans to enroll 1000 participants.
What's involved
You would give permission for leftover tissue samples from your medical care to be used for research. You might also provide blood, saliva, or oral swabs, and if you are an adult, potentially oral mucosal biopsies, skin biopsies, or nasal secretions.
Compensation
Not stated in the trial record.
Follow-up
The collection of samples for the biorepository is ongoing.

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NCT06303180

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Recruiting
Not specifiedAges 3–99Observational
National Institute on Deafness and Other Communication Disorders (NIDCD)
~1,000 participants
Updated 2025-11-14 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To create a biorepository of diseased and normal tissue specimens for research purposes.
Measured over Ongoing
Hearing Loss
Head and Neck Neoplasms
Hearing Disorders
Laryngeal Disease
1 sites across 1 states
Maryland1
  • Joshua M Levy, M.D. · PRINCIPAL_INVESTIGATOR · National Institute on Deafness and Other Communication Disorders (NIDCD)

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Eligibility criteria

Inclusion

Ability to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.
Ability of subject (or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
Have a hearing, balance, smell, taste, voice, speech or language condition for which the subject is under clinical care or research purposes under a separate Review Board (IRB) approved protocol; OR be a healthy volunteer aged at least 3 years, enrolled on an approved research protocol.

Exclusion

Have active symptomatic major organ disorders that would increase the risk of biopsy for research, including but not limited to bleeding disorders, ischemic heart disease, a recent myocardial infarction, active congestive heart failure or severe pulmonary dysfunction
Have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the subjects risk in participating. This will be determined at the discretion of the principal investigator.
  • To create a biorepository of diseased and normal tissue specimens for research purposes.Ongoing

    (Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders.(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies and nasal secretion collection, taken from subjects with head and neck disorders.