Biospecimen Procurement for the Study of Head and Neck Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 9
- 主要终点
- To created a biorepository of diseased and normal tissue specimens for research purposes
研究概览
简要总结
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.
详细描述
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 of Health (NIH). These studies require the collection of biospecimens for research purposes.
Studies performed may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for individuals with disorders of the head and neck affecting human communication.
Objectives:
-Primary: To create a biorepository of diseased and normal tissue specimens for research purposes from individuals with head and neck disorders.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •-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
研究组 & 干预措施
1
Subjects must be diagnosed with a disorder of the head and neck region
结局指标
主要结局
To created a biorepository of diseased and normal tissue specimens for research purposes
时间窗: 06/03/2026
The primary endpoint of this study is the creation of a head and neck biorepository from both surgical waste material and prospectively collected blood, saliva, oral swabs, oral mucosa biopsy and skin biopsy specimens.
次要结局
- To share repository specimens with other approved NIH protocols to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders of the ENT.(ongoing)