Biospecimen Procurement for NIDCD Clinical Protocols
Study Details
Study Description
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:
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Blood: Blood is drawn through a needle in the arm.
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Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.
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Saliva: They rinse their mouth with water and spit into a tube or cup.
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Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Background:
National Institute on Deafness and Other Communication Disorders (NIDCD) investigators are studying the natural history and treatment of diverse conditions of the head and neck affecting hearing, balance, smell, taste, swallowing, voice and speech at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.
Objectives:
Primary:
To create a biorepository of diseased and normal tissue specimens for research purposes. The samples will be obtained:
(Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders, as well as from patients treated at the Johns Hopkins Suburban Hospital Head and Neck Surgery Clinic (JHSH), and the Johns Hopkins Otolaryngology/Head and Neck Surgery Clinic Bethesda(JHOCB), Johns Hopkins Hospital (Broadway Baltimore, Green Spring , Sibley Memorial Hospital and Bayview), George Washington University Hospital (GWUH), MedStar Georgetown University Hospital and archived lung and laryngotracheal tissue from outside institutions.
(Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs. Participants aged 18 and older, may undergo oral mucosal biopsies and skin biopsies, taken from subjects with head and neck disorders
Secondary:
The specimens will be shared with the NCI Frederick Patient-Derived Xenograft (PDX) team, other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders. These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication.
Eligibility:
Subjects must be diagnosed with a disorder of the head and neck region
Design:
Up to 1000 subjects will be enrolled.
Part 1. Participants of all ages 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 subjects being treated at JHSH or the JHOCB, Johns Hopkins Hospital (Broadway Baltimore, Green Spring, Sibley Memorial Hospital and Bayview), George Washington University Hospital (GWUH), MedStar Georgetown University Hospital.
Part 2: Participants aged 3 and older 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 Subjects must be diagnosed with a disorder of the head and neck region |
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
- INCLUSION CRITERIA:
The subject may be eligible to participate in this study if they:
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Are able to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.
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Have 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
EXCLUSION CRITERIA:
The subject may not be eligible to participate in this study if they:
- Are unwilling to share waste specimens for research purposes
Additional exclusion criteria for the Part 2 prospective sample collection part of this protocol:
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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
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Have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the subjects' risk in participating. This will be determined at the discretion of the principal investigator
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Participants under the age of 3 are excluded from blood, saliva, oral swab collection
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Participants under the age of 18 are excluded from oral mucosal biopsies and skin biopsies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MedStar Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
| 2 | Johns Hopkins Hospital Sibley Memorial Hospital | Washington | District of Columbia | United States | 20016 |
| 3 | George Washington University Hospital | Washington | District of Columbia | United States | 20037 |
| 4 | Johns Hopkins Hospital Broadway Baltimore | Baltimore | Maryland | United States | 21205 |
| 5 | Johns Hopkins Hospital Bayview | Baltimore | Maryland | United States | 21224 |
| 6 | Johns Hopkins Hospital Greenspring | Baltimore | Maryland | United States | 21287 |
| 7 | Johns Hopkins Suburban Hospital | Bethesda | Maryland | United States | 20814 |
| 8 | Johns Hopkins Otolaryngology Clinic | Bethesda | Maryland | United States | 20817 |
| 9 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Clint T Allen, M.D., National Institute on Deafness and Other Communication Disorders (NIDCD)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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. Review.
- 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. Review.
- 180051
- 18-DC-0051