Collecting tissue samples for head and neck disorders
Biospecimen Procurement for the Study of Head and Neck Disorders
National Institutes of Health Clinical Center (CC) · NCT03429036
This study is collecting leftover tissue samples from people with head and neck disorders to help researchers learn more about these conditions and find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 3 Years to 120 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 9 sites (Washington D.C., District of Columbia and 8 other locations) |
| Trial ID | NCT03429036 on ClinicalTrials.gov |
What this trial studies
This study aims to create a biorepository of tissue samples from individuals diagnosed with various head and neck disorders, including hearing disorders and neoplasms. Participants will provide leftover tissue samples from surgical procedures or other research protocols, which will be used to enhance understanding and treatment of these conditions. The study involves screening participants through questionnaires and medical history assessments, with a focus on collecting both diseased and normal tissue specimens for future research. The goal is to support the development of new therapeutic agents and diagnostic models.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 3 and older who have been diagnosed with a head and neck disorder requiring tissue sample collection.
Not a fit: Patients who are unwilling to share their tissue samples for research purposes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments and diagnostic methods for patients with head and neck disorders.
How similar studies have performed: Other studies have successfully utilized similar biorepository approaches to advance research in various medical fields.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Washington D.C., District of Columbia and 8 other locations
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
- Johns Hopkins Hospital Sibley Memorial Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
- George Washington University Hospital — Washington D.C., District of Columbia, United States (RECRUITING)
- Johns Hopkins Hospital Broadway Baltimore — Baltimore, Maryland, United States (RECRUITING)
- Johns Hopkins Hospital Bayview — Baltimore, Maryland, United States (RECRUITING)
- Johns Hopkins Hospital Greenspring — Baltimore, Maryland, United States (RECRUITING)
- Johns Hopkins Suburban Hospital — Bethesda, Maryland, United States (RECRUITING)
- Johns Hopkins Otolaryngology Clinic — Bethesda, Maryland, United States (RECRUITING)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Clint T Allen, M.D. — National Cancer Institute (NCI)
- Study coordinator: Melissa L Wheatley
- Email: wheatleyml@nih.gov
- Phone: (240) 858-3391
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hearing Disorder, Oral Mucosal Disease, Pharyngeal Neoplasm, Head and Neck Neoplasms, Laryngeal Disease, Genomic DNA, DNA Banking, Tissue Sample