NCT03429036Recruiting
Biospecimen Procurement for Head and Neck Disorders
Biospecimen Procurement for the Study of Head and Neck Disorders
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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. ...
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 9 Feb 2018
- Start date
- 23 May 2018
- Primary completion date
- 3 Jun 2029
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Childhood cancers
- NCT number
- NCT03429036
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 23 May 2018 to the primary completion date, 3 Jun 2029
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Part 1:
- --Are unwilling to share waste specimens for research purposes
Criteria the registry did not label
- 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.
Age in the registry: 3 years to 120 years · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Hospital Greenspring Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Johns Hopkins Hospital Broadway Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Johns Hopkins Hospital Bayview Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Johns Hopkins Suburban Hospital Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| Johns Hopkins Otolaryngology Clinic Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
| MedStar Georgetown University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| Johns Hopkins Hospital Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
| George Washington University Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.