NIDCD Otolaryngology Clinical Protocol Biospecimen Bank
2 other identifiers
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2024
CompletedFirst Submitted
Initial submission to the registry
March 8, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2033
November 14, 2025
November 12, 2025
9.8 years
March 8, 2024
November 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To create a biorepository of diseased and normal tissue specimens for research purposes.
(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.
Ongoing
Secondary Outcomes (1)
To share specimens with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of
Ongoing
Study Arms (1)
1
Patients with head and neck conditions affecting hearing, balance, smell, taste, swallowing, voice and speech.
Eligibility Criteria
1000 subjects of any age, any race, ethnicity and gender. Only viable neonates will be enrolled. We are hoping to accrue about 100 subjects a year over 10 years. NIH employees and staff participating in an approved NIH protocol. There will be no collection or recruitment of healthy volunteers.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua M Levy, M.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2024
First Posted
March 12, 2024
Study Start
March 4, 2024
Primary Completion (Estimated)
December 30, 2033
Study Completion (Estimated)
December 30, 2033
Last Updated
November 14, 2025
Record last verified: 2025-11-12