Biospecimen Procurement for NIDCD Clinical Protocols

Summary

Participation Requirements

Description

Background: -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 (N...

Background: -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. Objectives: 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), Johns Hopkins Hospital (Broadway, Baltimore), George Washington University Hospital (WUH), MedStar Georgetown University Hospital 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. Participants, aged 18 and older, may undergo oral mucosal biopsies and skin biopsies, taken from subjects with head and neck disorders Secondary: The specimens will be shared with the NCI Frederick Patient-Derived Xenograft (PDX) team 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. -Eligibility: -- Subjects must be diagnosed with a disorder of the head and neck region Design: 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 adult participants aged 18 and older. No investigational or experimental therapy will be given as part of this protocol.

Tracking Information