Biospecimen Procurement for Head and Neck Disorders

Head and Neck Neoplasms Clinical Trial

Official title: Biospecimen Procurement for the Study of Head and Neck Disorders

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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.

• Secondary: To share specimens for Patient-Derived Xenograft (PDX) and organoid research, as well as analysis of cellular, molecular, genetic and genomic biology of normal processes and disorders.

Eligibility:

• Participants must be diagnosed with a disorder of the head and neck region.

• Age >= 3 years

Design:

• Up to 1000 participants will be enrolled.

• Part 1: Participants 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 other participating sites.

• Part 2: Participants 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. ;

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Hearing Disorder
• Hearing Disorders
• Laryngeal Disease
• Laryngeal Diseases
• Neoplasms
• Oral Mucosal Disease
• Pharyngeal Neoplasm
• Pharyngeal Neoplasms

• NCT number: NCT03429036
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Melissa Missy L Wheatley
• Phone: (240) 858-3391
• Email: wheatleyml@nih.gov
• Status: Recruiting
• Start date: May 23, 2018
• Completion date: December 3, 2026