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NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Re-verified, no change to tracked fields
  3. Eligibility criteria expanded, about 6 words Study description expanded, about 3 words Show 1 more changeShow less
    • Study description expanded, about 3 words
  4. 9 versions Re-verified since Sep 4, 2024, no change to tracked fieldsv9-v17
  5. Study Status, Study Descriptionv8
Show 6 earlier versionsHide 6 earlier versions
  1. Eligibility criteria shortened, about 33 words Study description shortened, about 20 wordsv7 Show 1 more changeShow less
    • Study description shortened, about 20 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv6
  3. Start date: Mar 7, 2024 to Mar 4, 2024v5
  4. Re-verified, no change to tracked fieldsv4
  5. Site contact updatedv3
  6. Start date changed from estimate of Mar 14, 2024 to Mar 7, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT06303180
Lead Sponsor National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions Hearing Loss, Head and Neck Neoplasms, Hearing Disorders, Laryngeal Disease
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov