RECRUITING

Biospecimen Procurement for Head and Neck Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Biospecimen Procurement for the Study of Head and Neck Disorders

Quick Facts

Study Start:2018-05-23
Study Completion:2026-12-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03429036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 3 and older.
  2. * Able to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.
  3. * 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.
  4. * Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.
  1. * Part 1:
  2. * 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):
  3. * 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
  4. * 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
  5. * Individuals under the age of 18 are excluded from oral mucosal biopsies and skin biopsies

Contacts and Locations

Study Contact

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

Principal Investigator

Clint T Allen, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

MedStar Georgetown University Hospital
Washington, District of Columbia, 20007
United States
Johns Hopkins Hospital Sibley Memorial Hospital
Washington, District of Columbia, 20016
United States
George Washington University Hospital
Washington, District of Columbia, 20037
United States
Johns Hopkins Hospital Broadway Baltimore
Baltimore, Maryland, 21205
United States
Johns Hopkins Hospital Bayview
Baltimore, Maryland, 21224
United States
Johns Hopkins Hospital Greenspring
Baltimore, Maryland, 21287
United States
Johns Hopkins Suburban Hospital
Bethesda, Maryland, 20814
United States
Johns Hopkins Otolaryngology Clinic
Bethesda, Maryland, 20817
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Clint T Allen, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-05-23
Study Completion Date2026-12-03

Study Record Updates

Study Start Date2018-05-23
Study Completion Date2026-12-03

Terms related to this study

Keywords Provided by Researchers

  • Genomic DNA
  • DNA Banking
  • Tissue Sample
  • Saliva
  • Blood Collection
  • Natural History

Additional Relevant MeSH Terms

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