Clinical trial Recruiting at 9 sites Observational Ages 3 to 120

Collecting tissue samples for head and neck disorders

Official title: Biospecimen Procurement for the Study of Head and Neck Disorders

Run by National Institutes of Health Clinical Center (CC) · NCT03429036 · Data updated 2026-11-12

This study is collecting leftover tissue samples from people with head and neck disorders to help researchers learn more about these conditions and find better treatments.

Quick facts

Study typeObservational
Ages3 Years to 120 Years
SexAll
Enrollment1000 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations9 sites (Washington D.C., District of Columbia and 8 other locations)
StatusRecruiting
StartedMay 23, 2018
Main results expectedJune 3, 2029
Study endsDecember 2, 2029
Registry record updatedNovember 9, 2026
Trial IDNCT03429036 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 3 and older who have been diagnosed with a head and neck disorder requiring tissue sample collection.

Probably not a fit

Patients who are unwilling to share their tissue samples for research purposes may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create a biorepository of tissue samples from individuals diagnosed with various head and neck disorders, including hearing disorders and neoplasms. Participants will provide leftover tissue samples from surgical procedures or other research protocols, which will be used to enhance understanding and treatment of these conditions. The study involves screening participants through questionnaires and medical history assessments, with a focus on collecting both diseased and normal tissue specimens for future research. The goal is to support the development of new therapeutic agents and diagnostic models.

Why it matters

Potential benefit: If successful, this study could lead to improved treatments and diagnostic methods for patients with head and neck disorders.

How similar studies have gone: Other studies have successfully utilized similar biorepository approaches to advance research in various medical fields.

Who can join: the full rules

Show full inclusion / exclusion criteria
* 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

Where it's running

  • MedStar Georgetown University Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
  • Johns Hopkins Hospital Sibley Memorial Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
  • George Washington University Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
  • Johns Hopkins Hospital Broadway Baltimore
    Baltimore, Maryland, United States
    Recruiting
  • Johns Hopkins Hospital Bayview
    Baltimore, Maryland, United States
    Recruiting
  • Johns Hopkins Hospital Greenspring
    Baltimore, Maryland, United States
    Recruiting
Show 3 more locations
  • Johns Hopkins Suburban Hospital
    Bethesda, Maryland, United States
    Recruiting
  • Johns Hopkins Otolaryngology Clinic
    Bethesda, Maryland, United States
    Recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Clint T Allen, M.D. — National Cancer Institute (NCI)
  • Study coordinator: Melissa L Wheatley
  • Email: wheatleyml@nih.gov
  • Phone: (240) 858-3391

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.