Neoplasms

All Conditions

Ear, Nose, and Throat Diseases

Nervous System Diseases

Symptoms and General Pathology

Mouth and Tooth Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Head and Neck Neoplasms

Hearing Disorders

Pharyngeal Neoplasms

Laryngeal Diseases

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Neurologic Manifestations

Respiratory Tract Diseases

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Subjects must be diagnosed with a disorder of the head and neck region

Melissa Missy L Wheatley

Clint T Allen, M.D.

Michael Hoa, M.D.

Nyall London, M.D.

Richard Lush, Ph.D.

National Cancer Institute Referral Office

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.

...

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.
* Secondary: To share specimens for Patient-Derived Xenograft (PDX) and organoid research, as well as analysis of cellular, molecular, genetic and genomic biology of normal processes and 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.

Biospecimen Procurement for Head and Neck Disorders

Biospecimen Procurement for the Study of Head and Neck Disorders

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.

National Cancer Institute (NCI)

Infections

Digestive System Diseases

Musculoskeletal Diseases

Behaviors and Mental Disorders

Rare Diseases

Bell Palsy

Facial Paralysis

Facies

Paralysis

Xerostomia

Deglutition Disorders

Polymyositis

Speech Disorders

Dysarthria

Myositis

Muscular Diseases

Neuromuscular Diseases

Language Disorders

Communication Disorders

Neurobehavioral Manifestations

Bell's Palsy

Idiopathic Inflammatory Myopathy

This study will assess the use of ultrasound-a test that uses sound waves to produce images-as a diagnostic tool for evaluating speech and swallowing.

The following categories of individuals may be eligible for this study: 1) healthy volunteers between 20 and 85 years old with normal speech and hearing, 2) patients 6 to 85 years old with developmental neurological deficits in speech or swallowing, and 3) patients with tumors of the oral cavity, pharynx or larynx being treated at the Greater Baltimore Medical Center.

Participants will undergo a 30-minute speech and oral motion evaluation, in which they imitate sounds, words and oral movements while a speech pathologist evaluates their lip, tongue and palate movements. They may also be asked to drink a small amount of water for examination of swallowing function.

For the ultrasound examination, a 3/4-inch transducer (device for transmitting and receiving sound waves) is placed under the participant's chin. While the transducer is in place, the subject 1) repeats sounds and a series of syllables in several sequences, 2) swallows three times with and without a small amount of water, and 3) swallows 3 teaspoons of non-fat pudding. The ultrasound images are recorded on tape for later analysis.

Studies conducted using ultrasound imaging at the NIH, Departments of Rehabilitation Medicine and Diagnostic Radiology, have demonstrated that ultrasound imaging can be used reliably to study speech and swallowing impairments in a variety of conditions and diseases. Since ultrasound is non-invasive with no reported bioeffects, it can be used repeatedly to follow the progression of a disease. Ultrasound imaging of the oral cavity during speech and swallowing allows easy visualization of the tongue/hyoid bone motion and transport of the bolus during swallowing and tongue surface configuration during speech. Images can be obtained in several planes for viewing muscular coordination and timing and specific measures can be obtained from digitized video images. Thus it has widespread clinical research implications for patients with disorders affecting the oral peripheral muscles, salivary gland flow and the central nervous system control of speech and swallowing. While ultrasound technology has been used extensively in Europe to evaluate tumors of the head and neck, its use in this country has been marginal. We plan to compare ultrasound evaluation of tumor staging, tumor volume, and tumor recurrence in patients with tumors of the larynx, oral cavity and hypopharynx. Currently, this is accomplished by CT or MRI scanning procedures. We plan to compare CT/MRI results with ultrasound to determine if this non-invasive technique can be utilized reliably for diagnosis and tracking of oropharyngeal tumors.

Ultrasound Evaluation of Tongue Movements in Speech and Swallowing

Exploration of the Diagnostic Capabilities of Ultrasound of the Oropharynx and Larynx

National Institutes of Health Clinical Center (CC)

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.

Study title	NCT ID	Conditions	Eligibility	Organization
Biospecimen Procurement for Head and Neck Disorders	NCT03429036	Hearing Disorde... Oral Mucosal Di... Pharyngeal Neop... Head and Neck N... Laryngeal Disea...	3 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Ultrasound Evaluation of Tongue Movements in Speech and Swallowing	NCT00001167	Otorhinolaryngo... Otorhinolaryngo... Pharyngeal Neop... Polymyositis Speech Disorder	-	National Institutes of Health Clinical Center (CC)
Biospecimen Procurement for Head and Neck Disorders	NCT03429036	Hearing Disorde... Oral Mucosal Di... Pharyngeal Neop... Head and Neck N... Laryngeal Disea...	3 Years - 120 Years	National Institutes of Health Clinical Center (CC)

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