Biospecimen Procurement for Head and Neck Disorders

NCT03429036 | Recruiting

• 2 other identifiers: 18005118-DC-0051
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Hearing Disorder; Pharyngeal Neoplasm; Head and Neck Neoplasms; Oral Mucosal Disease; Laryngeal Disease

Keywords

Genomic DNA; DNA Banking; Tissue Sample; Saliva; Blood Collection; Natural History

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  ongoing

Study Arms (1)

1

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

Eligibility Criteria

• Age: 3 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Part 1:
• Are unwilling to share waste specimens for research purposes
• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (9)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Johns Hopkins Hospital Sibley Memorial Hospital

Washington D.C., District of Columbia, 20016, United States

RECRUITING

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Johns Hopkins Hospital Broadway Baltimore

Baltimore, Maryland, 21205, United States

RECRUITING

Johns Hopkins Hospital Bayview

Baltimore, Maryland, 21224, United States

RECRUITING

Johns Hopkins Hospital Greenspring

Baltimore, Maryland, 21287, United States

RECRUITING

Johns Hopkins Suburban Hospital

Bethesda, Maryland, 20814, United States

RECRUITING

Johns Hopkins Otolaryngology Clinic

Bethesda, Maryland, 20817, United States

RECRUITING

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 25631445 BACKGROUND

• Monasta 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.

  PMID: 22558393 BACKGROUND

• Smith 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.

  PMID: 25640115 BACKGROUND

• Sievers 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. doi: 10.1038/s41698-026-01437-7. Online ahead of print.

  PMID: 42000944 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hearing Disorders; Pharyngeal Neoplasms; Head and Neck Neoplasms; Laryngeal Diseases

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases

Study Officials

• Clint T Allen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa L Wheatley

CONTACT

(240) 858-3391; wheatleyml@nih.gov

Clint T Allen, M.D.

CONTACT

(301) 402-4216; clint.allen@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 12, 2018
• Study Start: May 23, 2018
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-08-01

Locations

US (9)