Biospecimen Procurement for Head and Neck Disorders

Last updated: August 13, 2025
Sponsor: National Cancer Institute (NCI)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT03429036
180051
18-DC-0051
  • Ages 3-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:

  • Age 3 and older.

  • Able to provide their own consent, or for minors, a parent or guardian is able toconsent on their behalf.

  • Diagnosis of a condition of the head and neck for which removal of biologicalspecimens was indicated for clinical care or for research purposes under a separateReview Board (IRB) approved protocol.

  • Ability of subject (or Legally Authorized Representative (LAR)) to understand andthe willingness to sign a written informed consent document.

Exclusion

EXCLUSION CRITERIA:

  • Part 1:

--Are unwilling to share waste specimens for research purposes

  • Part 2: Additional exclusion criteria for the Part 2 prospective sample collectionpart of this protocol these criteria may be assessed prior to collection of thesamples but will not affect overall eligibility for the trial (i.e., Part 1):

  • have active symptomatic major organ disorders that would increase the risk ofbiopsy for research, including but not limited to bleeding disorders, ischemicheart disease, a recent myocardial infarction, active congestive heart failureor severe pulmonary dysfunction

  • have specific medical condition, such as a bleeding tendency where additionalbiopsies or phlebotomy procedures may increase the participants risk inparticipating. This will be determined at the discretion of the principalinvestigator

  • Individuals under the age of 18 are excluded from oral mucosal biopsies andskin biopsies

Study Design

Total Participants: 1000
Study Start date:
May 23, 2018
Estimated Completion Date:
December 03, 2026

Study 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.

Connect with a study center

  • George Washington University Hospital

    Washington, District of Columbia 20037
    United States

    Active - Recruiting

  • Johns Hopkins Hospital Sibley Memorial Hospital

    Washington, District of Columbia 20016
    United States

    Active - Recruiting

  • MedStar Georgetown University Hospital

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Johns Hopkins Hospital Bayview

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Johns Hopkins Hospital Broadway Baltimore

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • Johns Hopkins Hospital Greenspring

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Johns Hopkins Otolaryngology Clinic

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Johns Hopkins Suburban Hospital

    Bethesda, Maryland 20814
    United States

    Active - Recruiting

  • National Institutes of Health Clinical Center

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

  • Johns Hopkins Hospital Greenspring

    Lutherville-Timonium, Maryland 21093
    United States

    Site Not Available

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