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Protocol Details

Biospecimen Procurement for NIDCD Clinical Protocols

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-DC-0051

Sponsoring Institute

National Institute on Deafness and Other Communication Disorders (NIDCD)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3
Max Age: 99

Referral Letter Required

No

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Genomic DNA;
DNA Banking;
Tissue Sample;
Saliva;
Blood Collection

Recruitment Keyword(s)

None

Condition(s)

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

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Child Health and Human DevelopmentNational Institute on Deafness and Other Communication Disorders

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.

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Eligibility

INCLUSION CRITERIA:

The subject may be eligible to participate in this study if they:

-Are able to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.

-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:

- 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 subjects risk in participating. This will be determined at the discretion of the principal investigator

- Participants under the age of 3 are excluded from blood, saliva, oral swab collection

- Pregnant participants are excluded from oral mucosal biopsies and skin biopsies

- Participants under the age of 18 are excluded from oral mucosal biopsies and skin biopsies


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Citations:

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.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Carter Van Waes, M.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)



Susannah S. Wargo, C.R.N.P.
National Institute on Deafness and Other Communication Disorders (NIDCD)
BG 10 RM 5C409
10 CENTER DR
BETHESDA MD 20814
(301) 496-4887
swargo@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT03429036

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