Actively Recruiting

Age: 3Years - 120Years
All Genders
ID03429036

Biospecimen Procurement for the Study of Head and Neck Disorders

Led by National Cancer Institute (NCI) · Updated on 2026-04-29

1000

Participants Needed

9

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating disorders affecting the head and neck to improve understanding and aid in developing better treatments. This observational study aims to create a biorepository of both diseased and normal tissue samples from individuals with head and neck conditions. The research is conducted by the National Cancer Institute and focuses on collecting valuable biological materials for future studies related to these disorders. Participants diagnosed with head and neck conditions can contribute by allowing leftover tissue samples from their clinical care or previous research to be stored for study. The study has two parts: Part 1 involves sharing surgical waste specimens for research, while Part 2 includes additional sample collection such as blood draws, cheek swabs, saliva collection, and, for adults 18 and older, optional skin or mucosal biopsies. No experimental treatments are given during this study. During the study, participants will undergo screening including questionnaires, medical history review, and physical exams. Samples collected will be used for genetic and molecular research. The primary outcome is to establish a repository of tissue specimens by December 2026. Participant involvement may include providing permission for sample use, additional sample collection, and ongoing sharing of specimens for approved research projects. The study continues to share samples for cellular and genetic analysis to support future research on head and neck disorders.

CONDITIONS

Brief Title

Biospecimen Procurement for Head and Neck Disorders

Who Can Participate

Age: 3Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 3 and older
  • Able to provide own consent or have a parent/guardian consent for minors
  • Diagnosed with a head or neck condition requiring tissue removal for clinical care or research
  • Willingness and ability to sign informed consent
Not Eligible

You will not qualify if you...

  • Unwilling to share leftover tissue specimens for research (Part 1)
  • Active major organ disorders increasing biopsy risk, such as bleeding disorders or severe heart and lung conditions (Part 2)
  • Medical conditions increasing risk from biopsies or blood draws (Part 2)
  • Participants under 18 years are excluded from oral mucosal and skin biopsies (Part 2)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Varies depending on surgical schedule and specimen availability

Participants share leftover tissue specimens from surgical procedures and may provide additional biospecimens such as blood, saliva, oral swabs, or biopsies depending on age and eligibility.

1 or more visits depending on surgical procedures and additional biospecimen collection

Long-term Monitoring

Duration - Up to study completion in 2026

Participants may be followed for ongoing specimen collection and research use of biospecimens in approved studies.

Additional visits as needed depending on research requirements

Trial Site Locations

Total: 9 locations

1

MedStar Georgetown University Hospital

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

Actively Recruiting

2

Johns Hopkins Hospital Sibley Memorial Hospital

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

Actively Recruiting

3

George Washington University Hospital

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

Actively Recruiting

4

Johns Hopkins Hospital Broadway Baltimore

Baltimore, Maryland, United States, 21205

Actively Recruiting

5

Johns Hopkins Hospital Bayview

Baltimore, Maryland, United States, 21224

Actively Recruiting

6

Johns Hopkins Hospital Greenspring

Baltimore, Maryland, United States, 21287

Actively Recruiting

7

Johns Hopkins Suburban Hospital

Bethesda, Maryland, United States, 20814

Actively Recruiting

8

Johns Hopkins Otolaryngology Clinic

Bethesda, Maryland, United States, 20817

Actively Recruiting

9

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Melissa L Wheatley

C

Clint T Allen, M.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

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Cem M Sievers, Tian-Gen Chang, Yvette Robbins...

https://pubmed.ncbi.nlm.nih.gov/42000944