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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03429036
Other study ID # 180051
Secondary ID 18-DC-0051
Status Recruiting
Phase
First received
Last updated
Start date May 23, 2018
Est. completion date December 3, 2026

Study information

Verified date June 3, 2024
Source National Institutes of Health Clinical Center (CC)
Contact Melissa Missy L Wheatley
Phone (240) 858-3391
Email wheatleyml@nih.gov
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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. - Secondary: To share specimens for Patient-Derived Xenograft (PDX) and organoid research, as well as analysis of cellular, molecular, genetic and genomic biology of normal processes and 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 3, 2026
Est. primary completion date June 3, 2026
Accepts healthy volunteers No
Gender All
Age group 3 Years to 120 Years
Eligibility - 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 - participants under the age of 18 are excluded from oral mucosal biopsies and skin biopsies

Study Design


Locations

Country Name City State
United States Johns Hopkins Hospital Bayview Baltimore Maryland
United States Johns Hopkins Hospital Broadway Baltimore Baltimore Maryland
United States Johns Hopkins Hospital Greenspring Baltimore Maryland
United States Johns Hopkins Otolaryngology Clinic Bethesda Maryland
United States Johns Hopkins Suburban Hospital Bethesda Maryland
United States National Institutes of Health Clinical Center Bethesda Maryland
United States George Washington University Hospital Washington District of Columbia
United States Johns Hopkins Hospital Sibley Memorial Hospital Washington District of Columbia
United States MedStar Georgetown University Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Cancer Genome Atlas Network. Comprehensive genomic characterization of head and neck squamous cell carcinomas. Nature. 2015 Jan 29;517(7536):576-82. doi: 10.1038/nature14129. — View Citation

Monasta L, Ronfani L, Marchetti F, Montico M, Vecchi Brumatti L, Bavcar A, Grasso D, Barbiero C, Tamburlini G. Burden of disease caused by otitis media: systematic review and global estimates. PLoS One. 2012;7(4):e36226. doi: 10.1371/journal.pone.0036226. Epub 2012 Apr 30. — View Citation

Smith KA, Orlandi RR, Rudmik L. Cost of adult chronic rhinosinusitis: A systematic review. Laryngoscope. 2015 Jul;125(7):1547-56. doi: 10.1002/lary.25180. Epub 2015 Jan 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To created a biorepository of diseased and normal tissue specimens for research purposes 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. 06/03/2026
Secondary 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
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