Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT03429036

Conditions

Hearing Disorder

Oral Mucosal Disease

Pharyngeal Neoplasm

Head and Neck Neoplasms

Laryngeal Disease

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Not accepted

Study Details

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

Oral Mucosal Disease

Pharyngeal Neoplasm

Head and Neck Neoplasms

Laryngeal Disease

Study ID

NCT03429036

Start date

May 23, 2018

Status verified date

Aug 5, 2026

Completion date

Dec 2, 2029

Anticipated

Primary completion date

Jun 3, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Not accepted

  • 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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

1

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

Primary outcome measure

  • To created a biorepository of diseased and normal tissue specimens for research purposes [ Time Frame: 06/03/2026 ]

Central Contacts and Locations

Central contacts

Melissa L Wheatley

(240) 858-3391wheatleyml@nih.gov

Clint T Allen, M.D.

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

Locations

MedStar Georgetown University Hospital

Recruiting

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

Contacts

Michael Hoa, M.D.

301-435-3455michael.hoa@nih.gov

Johns Hopkins Hospital Sibley Memorial Hospital

Recruiting

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

Contacts

Nyall London, M.D.

801-547-7851nyall.london@nih.gov

George Washington University Hospital

Recruiting

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

Contacts

Richard Lush, Ph.D.

202-994-3647rmlush3@email.gwu.edu

Johns Hopkins Hospital Broadway Baltimore

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Nyall London, M.D.

801-547-7851nyall.london@nih.gov

Johns Hopkins Hospital Bayview

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Nyall London, M.D.

801-547-7851nyall.london@nih.gov

Johns Hopkins Hospital Greenspring

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Nyall London, M.D.

301-827-6933nyall.london@nih.gov

Johns Hopkins Suburban Hospital

Recruiting

Bethesda, Maryland, United States, 20814

Contacts

Nyall London, M.D.

801-547-7851nyall.london@nih.gov

Johns Hopkins Otolaryngology Clinic

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Nyall London, M.D.

801-547-7851nyall.london@nih.gov

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

National Cancer Institute Referral Office

888-624-1937ncimo_referrals@nih.gov

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 28, 2026

Last verified

Aug 5, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-08-28.