Biospecimen Procurement for NIDCD Clinical Protocols

Status:	Recruiting
Conditions:	Cancer, Other Indications
Therapuetic Areas:	Oncology, Other
Healthy:	No
Age Range:	3 - 99
Updated:	1/12/2019
Start Date:	May 23, 2018
End Date:	June 30, 2030
Contact:	Susannah S Wargo, C.R.N.P.
Email:	swargo@mail.nih.gov
Phone:	(301) 496-4887

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.

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)

- (Part 2)Participants aged 3 and older may have collection of blood, saliva, and/or
oral swabs, Non-pregnant 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 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.

- 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 non-pregnant adult participants aged 18
and older.

- No investigational or experimental therapy will be given as part of this protocol.

- 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

We found this trial at

sites

Johns Hopkins Otolaryngology Clinic

6420 Rockledge Drive
Bethesda, Maryland 20817

Phone: 301-896-3330

from

Bethesda, MD