Collection of biological samples for research on head and neck disorders
NIDCD Otolaryngology Clinical Protocol Biospecimen Bank
This study is collecting biological samples from people with head and neck disorders to see how these conditions develop and find better ways to diagnose and treat them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 3 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06303180 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals of any age with conditions affecting hearing, balance, smell, taste, voice, speech, or language.
Not a fit: Patients with active major organ disorders that increase biopsy risks may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved diagnosis and treatment options for patients with head and neck disorders.
How similar studies have performed: Other studies have successfully utilized biorepositories for similar conditions, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.