What this study is
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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Study details
- Official title
- Biospecimen Procurement for the Study of Head and Neck Disorders
- Sponsor
- National Cancer Institute (NCI)
- Conditions
- Hearing Disorder · Oral Mucosal Disease · Pharyngeal Neoplasm · Head and Neck Neoplasms · Laryngeal Disease
- Enrolling
- 1,000 people
- Starts
- 2018-05-23
- Est. completion
- 2029-12-02
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Years – 120 YearsSex ALLHealthy volunteers Not acceptedPart 1
You may qualify if
- 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.
You can't join if
- Part 1: --Are unwilling to share waste specimens for research purposes
Part 2
You may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
9 openContact for 5 of 9 open sites
- Nyall London, M.D. · Contact801-547-7851nyall.london@nih.gov
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
- Michael Hoa, M.D. · Contact301-435-3455michael.hoa@nih.gov
RecruitingJohns Hopkins Hospital Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
RecruitingGeorge Washington University Hospital
Washington D.C., District of Columbia, United States
- Richard Lush, Ph.D. · Contact202-994-3647rmlush3@email.gwu.edu
RecruitingJohns Hopkins Hospital Broadway Baltimore
Baltimore, Maryland, United States
RecruitingJohns Hopkins Hospital Bayview
Baltimore, Maryland, United States
RecruitingJohns Hopkins Hospital Greenspring
Baltimore, Maryland, United States
- Nyall London, M.D. · Contact301-827-6933nyall.london@nih.gov
RecruitingJohns Hopkins Suburban Hospital
Bethesda, Maryland, United States
RecruitingJohns Hopkins Otolaryngology Clinic
Bethesda, Maryland, United States
RecruitingNational Institutes of Health Clinical Center
Bethesda, Maryland, United States
- National Cancer Institute Referral Office · Contact888-624-1937ncimo_referrals@nih.gov
Recruiting
Study team
Sponsor
National Cancer Institute (NCI)
Study ID 180051
Principal investigator
Clint T Allen, M.D.
National Cancer Institute (NCI)
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.