NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Hearing Loss Clinical Trial

Official title:

NIDCD Otolaryngology Clinical Protocol Biospecimen Bank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06303180
• Other study ID #: 10001560
• Secondary ID: 001560-DC
• Status: Recruiting
• Start date: March 4, 2024
• Est. completion date: December 30, 2033

Study information

• Verified date: March 5, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Marcia L Mulquin, R.N.
• Phone: (240) 858-3752
• Email: mmulquin[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study Description:

National Institute on Deafness and Other Communication Disorders (NIDCD) investigators are studying the natural history and treatment of diverse conditions of the head and neck affecting hearing, balance, smell, taste, swallowing, voice and speech 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:

(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.

Secondary:

The specimens may be shared 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 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 head and neck biorepository from both surgical waste material and prospectively collected blood, saliva, oral swabs, oral mucosa biopsy and skin biopsy specimens.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 30, 2033
• Est. primary completion date: December 30, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 99 Years

Eligibility

• 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 condition of the head and neck for which removal of biological specimens was indicated for clinical care or for research purposes under a separate Review Board (IRB) approved protocol.

EXCLUSION CRITERIA:

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

Part 1:

-Are unwilling to share waste specimens for research purposes.

Part 2:

Additional exclusion criteria for the Part 2 prospective sample collection part of this protocol:

• 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.

• Participants ages 3 to <18 are excluded from nasal secretion collection, oral mucosal biopsies and skin biopsies.

• 3 years of age.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Hearing Disorders
• Hearing Loss
• Laryngeal Disease
• Laryngeal Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page