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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 : January 10, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) )

Tracking Information
First Submitted Date February 9, 2018
First Posted Date February 12, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date May 23, 2018
Estimated Primary Completion Date January 1, 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 9, 2018)
To created a biorepository of diseased and normal tissue specimens for research purposes [ Time Frame: 01-01-2030 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03429036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 9, 2018)
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: 01-01-2030 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biospecimen Procurement for NIDCD Clinical Protocols
Official Title Biospecimen Procurement for NIDCD Clinical Protocols
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.

Detailed 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 (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)
    • (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
  • Secondary:

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.

-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 non-pregnant adult participants aged 18 and older.

    • No investigational or experimental therapy will be given as part of this protocol.
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects must be diagnosed with a disorder of the head and neck region
Condition
  • Hearing Disorder
  • Oral Mucosal Disease
  • Pharyngeal Neoplasm
  • Head and Neck Neoplasms
  • Laryngeal Disease
Intervention Not Provided
Study Groups/Cohorts 1
Subjects must be diagnosed with a disorder of the head and neck region
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 9, 2018)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2030
Estimated Primary Completion Date January 1, 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:

The subject may be eligible to participate in this study if they:

  • Are able to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.
  • Have 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

EXCLUSION CRITERIA:

The subject may not be eligible to participate in this study if they:

- Are unwilling to share waste specimens for research purposes

Additional exclusion criteria for the Part 2 prospective sample collection part of this protocol:

  • 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 subjects risk in participating. This will be determined at the discretion of the principal investigator
  • Participants under the age of 3 are excluded from blood, saliva, oral swab collection
  • Pregnant participants are excluded from oral mucosal biopsies and skin biopsies
  • Participants under the age of 18 are excluded from oral mucosal biopsies and skin biopsies
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Susannah S Wargo, C.R.N.P. (301) 496-4887 swargo@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03429036
Other Study ID Numbers 180051
18-DC-0051
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute on Deafness and Other Communication Disorders (NIDCD) )
Study Sponsor National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborators Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Carter Van Waes, M.D. National Institute on Deafness and Other Communication Disorders (NIDCD)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date January 2, 2019