Biospecimen Procurement for Head and Neck Disorders

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.

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 Overview

• Status: Recruiting
• Conditions: Head and Neck Neoplasms; Hearing Disorder; Laryngeal Disease; Oral Mucosal Disease; Pharyngeal Neoplasm

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Clint T Allen, M.D.; Phone Number: (301) 402-4216; Email: clint.allen@nih.gov
• Study Contact Backup: Name: Melissa L Wheatley; Phone Number: (240) 858-3391; Email: wheatleyml@nih.gov

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Recruiting
      • MedStar Georgetown University Hospital
      • Contact: Michael Hoa, M.D.; Phone Number: 301-435-3455; Email: michael.hoa@nih.gov
    • Washington D.C., District of Columbia, United States, 20037
      • Recruiting
      • George Washington University Hospital
      • Contact: Richard Lush, Ph.D.; Phone Number: 202-994-3647; Email: rmlush3@email.gwu.edu
    • Washington D.C., District of Columbia, United States, 20016
      • Recruiting
      • Johns Hopkins Hospital Sibley Memorial Hospital
      • Contact: Nyall London, M.D.; Phone Number: 801-547-7851; Email: nyall.london@nih.gov
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins Hospital Broadway Baltimore
      • Contact: Nyall London, M.D.; Phone Number: 801-547-7851; Email: nyall.london@nih.gov
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Johns Hopkins Hospital Bayview
      • Contact: Nyall London, M.D.; Phone Number: 801-547-7851; Email: nyall.london@nih.gov
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital Greenspring
      • Contact: Nyall London, M.D.; Phone Number: 301-827-6933; Email: nyall.london@nih.gov
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: National Cancer Institute Referral Office; Phone Number: 888-624-1937; Email: ncimo_referrals@nih.gov
    • Bethesda, Maryland, United States, 20814
      • Recruiting
      • Johns Hopkins Suburban Hospital
      • Contact: Nyall London, M.D.; Phone Number: 801-547-7851; Email: nyall.london@nih.gov
    • Bethesda, Maryland, United States, 20817
      • Recruiting
      • Johns Hopkins Otolaryngology Clinic
      • Contact: Nyall London, M.D.; Phone Number: 801-547-7851; Email: nyall.london@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

• INCLUSION CRITERIA:
• 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.

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):

  • 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; Subjects must be diagnosed with a disorder of the head and neck region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Clint T Allen, M.D., National Cancer Institute (NCI)

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2018
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): December 3, 2026

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Natural History; Saliva; Genomic DNA; DNA Banking; Tissue Sample; Blood Collection
• Additional Relevant MeSH Terms: Neurologic Manifestations; Stomatognathic Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Head and Neck Neoplasms; Pharyngeal Neoplasms; Hearing Disorders; Laryngeal Diseases
• Other Study ID Numbers: 180051; 18-DC-0051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No