Biospecimen Procurement for NIDCD Clinical Protocols
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|ClinicalTrials.gov Identifier: NCT03429036|
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : March 24, 2020
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.
To create a repository of tissue samples and data to better study conditions of the head and neck.
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.
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.
|Condition or disease|
|Hearing Disorder Oral Mucosal Disease Pharyngeal Neoplasm Head and Neck Neoplasms Laryngeal Disease|
-National Institute on Deafness and Other Communication Disorders (NIDCD) investigators are studying the natural history and treatment of diverse conditions of the head and neck affecting hearing, balance, smell, taste, swallowing, voice and speech at the National Institutes of Health (NIH). These studies require the collection of biospecimens for research purposes.
Primary: To create a biorepository of diseased and normal tissue specimens for research purposes. The samples will be obtained:
- (Part 1) From surgical waste materials from participants of all ages in NIH protocols who have head and neck disorders, as well as from patients treated at the Johns Hopkins Suburban Hospital Head and Neck Surgery Clinic (JHSH), and the Johns Hopkins Otolaryngology/Head and Neck Surgery Clinic Bethesda.(JHOCB) an archived lung and laryngotracheal tissue from outside institutions.
- (Part 2) Participants aged 3 and older may have collection of blood, saliva, and/or oral swabs, Non-pregnant participants, aged 18 and older, may undergo oral mucosal biopsies and skin biopsies, taken from subjects with head and neck disorders
The specimens will be shared with other approved protocols or may be used under this protocol to conduct analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders. These laboratory studies may support development of future protocols that include new therapeutic agents, novel treatment approaches, and new prognostic and diagnostic models for subjects with disorders of the head and neck affecting human communication.
-- Subjects must be diagnosed with a disorder of the head and neck region
- Up to 1000 subjects will be enrolled.
- Part 1. Participants of all ages with head and neck disorders will be asked to share waste material from surgical procedures to create a biorepository of diseased and normal specimens for research. The participants will be enrolled prior to the surgery or they may be enrolled retrospectively and asked to share pathology specimens and slides previously collected that are no longer required for their medical care.
- Participants will be recruited from surgical protocols at the National Institutes of Health (NIH) Clinical Center or from subjects being treated at JHSH or the JHOCB.
Part 2: Participants aged 3 and older who have agreed to share surgical waste material may be asked to provide additional blood, saliva, and/or oral swabs. In addition, oral mucosal or skin biopsies may be obtained from non-pregnant adult participants aged 18 and older.
- No investigational or experimental therapy will be given as part of this protocol.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Biospecimen Procurement for NIDCD Clinical Protocols|
|Actual Study Start Date :||May 23, 2018|
|Estimated Primary Completion Date :||June 3, 2026|
|Estimated Study Completion Date :||December 3, 2026|
Subjects must be diagnosed with a disorder of the head and neck region
- To created a biorepository of diseased and normal tissue specimens for research purposes [ Time Frame: 06/03/26 ]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 biopsyspecimens.
- 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. [ Time Frame: ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03429036
|Contact: Susannah S Wargo, C.R.N.P.||(301) firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Suburban Hospital||Recruiting|
|Bethesda, Maryland, United States, 20814|
|Contact: Clint Allen, MD 301-896-3330|
|Johns Hopkins Otolaryngology Clinic||Recruiting|
|Bethesda, Maryland, United States, 20817|
|Contact: Clint Allen, MD 301-896-3330|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Carter Van Waes, M.D.||National Institute on Deafness and Other Communication Disorders (NIDCD)|