Hearing DisorderNCT03429036
Biospecimen Procurement for Head and Neck Disorders
An observational study of Hearing Disorder and Oral Mucosal Disease, run by National Cancer Institute (NCI) at 9 sites in United States.
Trial summary
Background: Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research. Objective: To create a repository of tissue samples and data to better study conditions of the head and neck. Read more about this study
- Who is it for?
- Ages 3 to 120 years
- Conditions the study is for
- Hearing Disorder, Oral Mucosal Disease, Pharyngeal Neoplasm
- How many people
- 1,000 participants
- Where
- 9 sitesUnited States
- Study dates
- 23 May 2018to 2 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The participants in this protocol will be a population with serious head and neck disorders, including cancer, and are anticipated to have a large number of adverse events completely unrelated to this protocol. Adverse events that are unrelated to the research under this protocol will not be reported to the IRB immediately or at the time of CR.
Who may be able to join
- Age 3 and older.
- Able to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.
- Diagnosis of 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.
- Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.
Who cannot join
- 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 these criteria may be assessed prior to collection of the samples but will not affect overall eligibility for the trial (i.e., Part 1):
- 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 participants' risk in participating. This will be determined at the discretion of the principal investigator
- Individuals under the age of 18 are excluded from oral mucosal biopsies and skin biopsies
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Johns Hopkins Hospital Broadway Baltimore
Baltimore, Maryland, 21205
Nyall London, M.D., 801-547-7851, nyall.london@nih.gov
- Recruiting
Johns Hopkins Hospital Bayview
Baltimore, Maryland, 21224
Nyall London, M.D., 801-547-7851, nyall.london@nih.gov
- Recruiting
Johns Hopkins Hospital Greenspring
Baltimore, Maryland, 21287
Nyall London, M.D., 301-827-6933, nyall.london@nih.gov
- Recruiting
Johns Hopkins Suburban Hospital
Bethesda, Maryland, 20814
Nyall London, M.D., 801-547-7851, nyall.london@nih.gov
- Recruiting
Johns Hopkins Otolaryngology Clinic
Bethesda, Maryland, 20817
Nyall London, M.D., 801-547-7851, nyall.london@nih.gov
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
National Cancer Institute Referral Office, 888-624-1937, ncimo_referrals@nih.gov
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Michael Hoa, M.D., 301-435-3455, michael.hoa@nih.gov
- Recruiting
Johns Hopkins Hospital Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
Nyall London, M.D., 801-547-7851, nyall.london@nih.gov
- Recruiting
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Richard Lush, Ph.D., 202-994-3647, rmlush3@email.gwu.edu
About this study
Official title: Biospecimen Procurement for the Study of Head and Neck Disorders
Background:
Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research.
Read more
Objective:
To create a repository of tissue samples and data to better study conditions of the head and neck.
Eligibility:
People who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2.
Design:
Participants will be screened with a questionnaire, medical history, and physical exam.
Part 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used.
If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2.
Part 2: Participants will have additional samples collected. These could be:
- Blood: Blood is drawn through a needle in the arm.
- Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.
- Saliva: They rinse their mouth with water and spit into a tube or cup.
- Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.
- Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed.
Participants samples will be used for future research, including genetic testing.
Read the detailed description
Background:
NCI Head and Neck Clinical Research Program (H\&N CRP) investigators are studying the natural history and treatment of diverse conditions of the head and neck at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.
Studies performed may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for individuals with disorders of the head and neck affecting human communication.
Objectives:
-Primary: To create a biorepository of diseased and normal tissue specimens for research purposes from individuals with head and neck disorders.
Eligibility:
- Participants must be diagnosed with a disorder of the head and neck region.
- Age >= 3 years
Design:
- Up to 1000 participants will be enrolled.
- Part 1: Participants with head and neck disorders will be asked to share waste material from surgical procedures to create a biorepository of diseased and normal specimens for research. The participants will be enrolled prior to the surgery, or they may be enrolled retrospectively and asked to share pathology specimens and slides previously collected that are no longer required for their medical care. Participants will be recruited from surgical protocols at the National Institutes of Health (NIH) Clinical Center or from other participating sites.
- Part 2: Participants who have agreed to share surgical waste material may be asked to provide additional blood, saliva, and/or oral swabs. In addition, oral mucosal or skin biopsies may be obtained from adult participants aged 18 and older.
- No investigational or experimental therapy will be given as part of this protocol.
- Conditions
- Hearing Disorder, Oral Mucosal Disease, Pharyngeal Neoplasm, Head and Neck Neoplasms, Laryngeal Disease
- Keywords
- Genomic DNA, DNA Banking, Tissue Sample, Saliva, Blood Collection, Natural History
- Medical subject headings
- Hearing Disorders, Pharyngeal Neoplasms, Head and Neck Neoplasms, Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects must be diagnosed with a disorder of the head and neck region |
What is being measured
The primary outcome is the main question the study is designed to answer.
To created a biorepository of diseased and normal tissue specimens for research purposes
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.
Measured: 06/03/2026
Secondary outcomes (1)
To share repository specimens with other approved NIH protocols to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders of the ENT.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start23 May 2018
- Primary completion3 Jun 2029 (estimated)
- Study completion2 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hearing DisorderStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Clint T Allen, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429036
- Sponsor's protocol ID
- 180051
- Other IDs
- 18-DC-0051
- Status last verified
- 13 Oct 2026
- First submitted
- 9 Feb 2018
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cancer Genome Atlas Network. Comprehensive genomic characterization of head and neck squamous cell carcinomas. Nature. 2015 Jan 29;517(7536):576-82. doi: 10.1038/nature14129.
PubMed 25631445Monasta L, Ronfani L, Marchetti F, Montico M, Vecchi Brumatti L, Bavcar A, Grasso D, Barbiero C, Tamburlini G. Burden of disease caused by otitis media: systematic review and global estimates. PLoS One. 2012;7(4):e36226. doi: 10.1371/journal.pone.0036226. Epub 2012 Apr 30.
PubMed 22558393Smith KA, Orlandi RR, Rudmik L. Cost of adult chronic rhinosinusitis: A systematic review. Laryngoscope. 2015 Jul;125(7):1547-56. doi: 10.1002/lary.25180. Epub 2015 Jan 30.
PubMed 25640115Sievers CM, Chang TG, Robbins Y, Friedman J, Craveiro M, Yang X, Silvin C, Redman JM, Soon-Shiong P, Lassoued W, Quezado M, Mydlarz W, Judd NP, Schlom J, Gulley J, Ruppin E, Allen CT. GZMK expression within activated intratumoral T-cell subsets reflects differentiation efficiency and predicts response to cancer immunotherapy. NPJ Precis Oncol. 2026 Apr 18;10(1):237. doi: 10.1038/s41698-026-01437-7.
PubMed 42000944
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biospecimen Procurement for the Study of Head and Neck Disorders
- ClinicalTrials.gov ID
- NCT03429036
- Acronym / sponsor ID
- 180051
- Conditions
- Hearing Disorder, Oral Mucosal Disease, Pharyngeal Neoplasm, Head and Neck Neoplasms, Laryngeal Disease
- Keywords
- Genomic DNA, DNA Banking, Tissue Sample, Saliva, Blood Collection, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 May 2018 (actual)
- Primary completion
- 3 Jun 2029 (estimated)
- Study completion
- 2 Dec 2029 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research.
Objective:
To create a repository of tissue samples and data to better study conditions of the head and neck.
Eligibility:
People who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2.
Design:
Participants will be screened with a questionnaire, medical history, and physical exam.
Part 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used.
If participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2.
Part 2: Participants will have additional samples collected. These could be:
- Blood: Blood is drawn through a needle in the arm.
- Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.
- Saliva: They rinse their mouth with water and spit into a tube or cup.
- Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.
- Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed.
Participants samples will be used for future research, including genetic testing.
Detailed description
Background:
NCI Head and Neck Clinical Research Program (H\&N CRP) investigators are studying the natural history and treatment of diverse conditions of the head and neck at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.
Studies performed may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for individuals with disorders of the head and neck affecting human communication.
Objectives:
-Primary: To create a biorepository of diseased and normal tissue specimens for research purposes from individuals with head and neck disorders.
Eligibility:
- Participants must be diagnosed with a disorder of the head and neck region.
- Age >= 3 years
Design:
- Up to 1000 participants will be enrolled.
- Part 1: Participants with head and neck disorders will be asked to share waste material from surgical procedures to create a biorepository of diseased and normal specimens for research. The participants will be enrolled prior to the surgery, or they may be enrolled retrospectively and asked to share pathology specimens and slides previously collected that are no longer required for their medical care. Participants will be recruited from surgical protocols at the National Institutes of Health (NIH) Clinical Center or from other participating sites.
- Part 2: Participants who have agreed to share surgical waste material may be asked to provide additional blood, saliva, and/or oral swabs. In addition, oral mucosal or skin biopsies may be obtained from adult participants aged 18 and older.
- No investigational or experimental therapy will be given as part of this protocol.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Subjects must be diagnosed with a disorder of the head and neck region |
Who may qualify
- Ages
- 3 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The participants in this protocol will be a population with serious head and neck disorders, including cancer, and are anticipated to have a large number of adverse events completely unrelated to this protocol. Adverse events that are unrelated to the research under this protocol will not be reported to the IRB immediately or at the time of CR.
Key inclusion criteria (4 listed)
- Age 3 and older.
- Able to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.
- Diagnosis of 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.
- Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (6 listed)
- 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 these criteria may be assessed prior to collection of the samples but will not affect overall eligibility for the trial (i.e., Part 1):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To created a biorepository of diseased and normal tissue specimens for research purposes
Time frame: 06/03/2026
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.
1 secondary outcome
To share repository specimens with other approved NIH protocols to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders of the ENT.
Time frame: ongoing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 25631445Cancer Genome Atlas Network. Comprehensive genomic characterization of head and neck squamous cell carcinomas. Nature. 2015 Jan 29;517(7536):576-82. doi: 10.1038/nature14129.
- Background: PubMed 22558393Monasta L, Ronfani L, Marchetti F, Montico M, Vecchi Brumatti L, Bavcar A, Grasso D, Barbiero C, Tamburlini G. Burden of disease caused by otitis media: systematic review and global estimates. PLoS One. 2012;7(4):e36226. doi: 10.1371/journal.pone.0036226. Epub 2012 Apr 30.
- Background: PubMed 25640115Smith KA, Orlandi RR, Rudmik L. Cost of adult chronic rhinosinusitis: A systematic review. Laryngoscope. 2015 Jul;125(7):1547-56. doi: 10.1002/lary.25180. Epub 2015 Jan 30.
- Derived from this study: PubMed 42000944Sievers CM, Chang TG, Robbins Y, Friedman J, Craveiro M, Yang X, Silvin C, Redman JM, Soon-Shiong P, Lassoued W, Quezado M, Mydlarz W, Judd NP, Schlom J, Gulley J, Ruppin E, Allen CT. GZMK expression within activated intratumoral T-cell subsets reflects differentiation efficiency and predicts response to cancer immunotherapy. NPJ Precis Oncol. 2026 Apr 18;10(1):237. doi: 10.1038/s41698-026-01437-7.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clint T Allen, M.D. principal investigator
National Cancer Institute (NCI)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Disorder and Oral Mucosal Disease, run by National Cancer Institute (NCI) at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa L Wheatley ((240) 858-3391, wheatleyml@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To created a biorepository of diseased and normal tissue specimens for research purposes (time frame: 06/03/2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429036, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.