Clinical trial NCT06303180: NIDCD Otolaryngology Clinical Protocol Biospecimen Bank
Official title: NIDCD Otolaryngology Clinical Protocol Biospecimen Bank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hearing Loss
Head and Neck Neoplasms
Hearing Disorders
Laryngeal Disease
Keywords: Hearing
Balance
Speech
Taste
SMELL
Tissue Sample
Genomic DNA
Saliva
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-03-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: Study Description:

National Institute on Deafness and Other Communication Disorders (NIDCD) investigators are studying the natural history and treatment of diverse conditions affecting hearing, balance, smell, taste, voice, speech and language at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.

Objectives:

Primary:

To create a biorepository of diseased and normal tissue specimens for research purposes. The samples will be obtained:

* From surgical waste materials from participants of all ages in NIH protocols who have hearing, balance, smell, taste, voice, speech and language disorders.
* 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.

Secondary:

The specimens may be shared with other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders. These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication.

Endpoints:

The primary endpoint of this study is the creation of a NIDCD biorepository from both surgical waste material and collected blood, saliva, oral swabs, nasal secretions, oral mucosa biopsy and skin biopsy specimens.

Eligibility 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.

Primary outcomes:
measure: To create a biorepository of diseased and normal tissue specimens for research purposes.
timeFrame: Ongoing
Secondary outcomes:
measure: 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
timeFrame: Ongoing
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Joshua M Levy, M.D.
role: PRINCIPAL_INVESTIGATOR
References: