Status:
RECRUITING
Biospecimen Procurement for Head and Neck Disorders
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Hearing Disorder
Oral Mucosal Disease
Eligibility:
All Genders
3-120 years
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 rese...
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 o...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 23 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 3 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03429036
Start Date
May 23 2018
End Date
December 3 2026
Last Update
August 14 2025
Active Locations (9)
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1
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
2
Johns Hopkins Hospital Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
3
George Washington University Hospital
Washington D.C., District of Columbia, United States, 20037
4
Johns Hopkins Hospital Broadway Baltimore
Baltimore, Maryland, United States, 21205