Official Title
Biospecimen Procurement for the Study of Head and Neck Disorders
Brief Title
Biospecimen Procurement for Head and Neck Disorders
Protocol ID
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 Period
-
Enrollment Count
1,000 participants
Eligibility Criteria
- 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
- Individuals under the age of 18 are excluded from oral mucosal biopsies and
skin biopsies
Filters
Hearing Disorder
Oral Mucosal Disease
Pharyngeal Neoplasm
Head and Neck Neoplasms
Laryngeal Disease
RECRUITING
CHILD
ADULT
OLDER_ADULT