Protocol Details
Biospecimen Procurement for the Study of Head and Neck Disorders
This study is currently recruiting participants.
Summary
Number |
18-DC-0051 |
Sponsoring Institute |
National Cancer Institute (NCI) |
Recruitment Detail |
Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 120 Years |
Referral Letter Required |
No |
Population Exclusion(s) |
None |
Keywords |
Genomic DNA;
DNA Banking;
Tissue Sample;
Saliva;
Blood Collection;
Natural History |
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 Cancer Institute |
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.
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
--Individuals under the age of 18 are excluded from oral mucosal biopsies and skin biopsies
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.
Contacts:
Clinical Trials Number:
NCT03429036