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Biospecimen Procurement for Head and Neck Disorders

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ClinicalTrials.gov Identifier: NCT03429036
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description
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Brief 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.


Condition or disease
Hearing Disorder Oral Mucosal Disease Pharyngeal Neoplasm Head and Neck Neoplasms Laryngeal Disease

Detailed 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Biospecimen Procurement for the Study of Head and Neck Disorders
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : June 3, 2026
Estimated Study Completion Date : December 3, 2026
Groups and Cohorts
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Group/Cohort
1
Subjects must be diagnosed with a disorder of the head and neck region


Outcome Measures
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Primary Outcome Measures :
  1. To created a biorepository of diseased and normal tissue specimens for research purposes [ Time Frame: 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.


Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The participants in this protocol will be a population with serious head and neck disorders, including cancer, and are anticipated to have a large number of adverse events completely unrelated to this protocol. Adverse events that are unrelated to the research under this protocol will not be reported to the IRB immediately or at the time of CR.
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
    • participants under the age of 18 are excluded from oral mucosal biopsies and skin biopsies
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
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Contact: Melissa Missy L Wheatley (240) 858-3391 wheatleyml@nih.gov
Contact: Clint T Allen, M.D. (301) 402-4216 clint.allen@nih.gov

Locations
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United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Michael Hoa, M.D.    301-435-3455    michael.hoa@nih.gov   
Johns Hopkins Hospital Sibley Memorial Hospital Recruiting
Washington, District of Columbia, United States, 20016
Contact: Nyall London, M.D.    801-547-7851    nyall.london@nih.gov   
George Washington University Hospital Recruiting
Washington, District of Columbia, United States, 20037
Contact: Richard Lush, Ph.D.    202-994-3647    rmlush3@email.gwu.edu   
United States, Maryland
Johns Hopkins Hospital Broadway Baltimore Recruiting
Baltimore, Maryland, United States, 21205
Contact: Nyall London, M.D.    801-547-7851    nyall.london@nih.gov   
Johns Hopkins Hospital Bayview Recruiting
Baltimore, Maryland, United States, 21224
Contact: Nyall London, M.D.    801-547-7851    nyall.london@nih.gov   
Johns Hopkins Hospital Greenspring Recruiting
Baltimore, Maryland, United States, 21287
Contact: Nyall London, M.D.    301-827-6933    nyall.london@nih.gov   
Johns Hopkins Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Contact: Nyall London, M.D.    801-547-7851    nyall.london@nih.gov   
Johns Hopkins Otolaryngology Clinic Recruiting
Bethesda, Maryland, United States, 20817
Contact: Nyall London, M.D.    801-547-7851    nyall.london@nih.gov   
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: National Cancer Institute Referral Office    888-624-1937    ncimo_referrals@nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Clint T Allen, M.D. National Cancer Institute (NCI)
More Information
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Additional Information:

Publications:

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03429036    
Other Study ID Numbers: 180051
18-DC-0051
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: April 30, 2024
Last Verified: January 8, 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Genomic DNA
DNA Banking
Tissue Sample
 Saliva
Blood Collection
Natural History
Additional relevant MeSH terms:
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Neoplasms
Head and Neck Neoplasms
Pharyngeal Neoplasms
Laryngeal Diseases
Hearing Disorders
Neoplasms by Site
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Stomatognathic Diseases