NCT03429036 Biospecimen Procurement for Head and Neck Disorders
| NCT ID | NCT03429036 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Hearing Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2018-05-23 |
| Primary Completion | 2029-06-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2018-05-23 with a primary completion date of 2029-06-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Clint T Allen, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT03429036 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 120 Years, studying Hearing Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03429036 currently recruiting?
Yes, NCT03429036 is actively recruiting participants. Contact the research team at wheatleyml@nih.gov for enrollment information.
Where is the NCT03429036 trial being conducted?
This trial is being conducted at Washington D.C., United States, Washington D.C., United States, Washington D.C., United States, Baltimore, United States and 5 additional locations.
Who is sponsoring the NCT03429036 clinical trial?
NCT03429036 is sponsored by National Cancer Institute (NCI). The principal investigator is Clint T Allen, M.D. at National Cancer Institute (NCI). The trial plans to enroll 1,000 participants.