Collection of biological samples for research on head and neck disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create a biorepository of biological samples from individuals with disorders affecting hearing, balance, smell, taste, voice, speech, and language. Participants will provide leftover tissue samples collected during routine medical care or research, along with relevant clinical information. The samples will be used to study the natural history and treatment of these conditions, potentially leading to new diagnostic and therapeutic approaches. Individuals aged 3 and older may also provide blood, saliva, and oral swabs, while those 18 and older may undergo additional biopsies.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* 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 CRITERIA

An individual who meets any of the following criteria will be excluded from participation in this study:

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Joshua M Levy, M.D. — National Institute on Deafness and Other Communication Disorders (NIDCD)
• Study coordinator: Maame S Akumatey
• Email: maame.akumatey@nih.gov
• Phone: (227) 233-0452

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.