Biospecimen Procurement for Head and Neck Disorders

Recruiting

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

• Registration Number: NCT03429036
• Lead Sponsor: National Cancer Institute (NCI)

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.

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 Timeline

• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-12
• Study Start: 2018-05-23
• Status Verified: 2025-03-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-05
• Primary Completion: 2026-06-03
• Study Completion: 2026-12-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To created a biorepository of diseased and normal tissue specimens for research purposes	06/03/2026	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States

Johns Hopkins Hospital Bayview; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Hospital Sibley Memorial Hospital; 🇺🇸 Washington, District of Columbia, United States

Johns Hopkins Hospital Broadway Baltimore; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Hospital Greenspring; 🇺🇸 Baltimore, Maryland, United States

Johns Hopkins Suburban Hospital; 🇺🇸 Bethesda, Maryland, United States

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States

Johns Hopkins Otolaryngology Clinic; 🇺🇸 Bethesda, Maryland, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States