An observational study in Hearing Disorder, Oral Mucosal Disease and Pharyngeal Neoplasm, sponsored by National Cancer Institute (NCI). Recruiting at 9 sites in United States. Open to participants aged 3 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Cancer Institute (NCI) · Observational
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:
Participants samples will be used for future research, including genetic testing.
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:
Design:
Up to 1000 participants will be enrolled.
65 studies on the registry are indexed under Hearing Disorders; 17 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 146 across 18 observational studies indexed under Hearing Disorders.
Browse Hearing Disorders studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
EXCLUSION CRITERIA:
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):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects must be diagnosed with a disorder of the head and neck region
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.
Time frame: 06/03/2026
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
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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