RECRUITING

Characterization of Diseases With Salivary Gland Involvement

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: \- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life. Studying people who have a disease that affects their salivary gland(s) may teach researchers about the disorders and their genetics. Objectives: \- To study salivary gland diseases and disorders. To collect data and samples from people with salivary gland problems and their relatives. Eligibility: * People more than 4 years old who have or are suspected to have a disease involving salivary glands. * Their relatives more than 4 years old. * Healthy volunteers 18 years or older. Design: * Participants may be screened with: * Medical history * Physical exam * Blood and urine tests * General oral and dental history and exam * Saliva collection * Eye exam and test for dry eyes * Health questionnaires (adults) * Biopsy of some minor salivary glands. A small incision will be made on the inside of the lower lip and several tiny salivary glands will be removed. * Participants will have 2-3 visits. These may include: * Repeats of some screening tests * Ultrasounds of some glands. Researchers will put some gel on the face, then press on it with a smooth wand. * Adults may have other biopsies * A small catheter inserted into the opening of the parotid gland duct on the inside of the cheek. A saline solution (in a syringe) will fill the duct. * Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup * Scrapings collected from teeth, tongue, and cheeks

Official Title

Characterization of Diseases With Salivary Gland Involvement

Quick Facts

Study Start:2015-04-03
Study Completion:2032-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02327884

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:4 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Persons older than 4 years of age, affected with or suspected of being affected with a disease/disorder involving the salivary glands or who is a relative of a person who is affected with these diseases/disorders.
  1. * Anyone not able to give consent/assent or parental/guardian consent
  2. * NIH employees who report directly to the principal investigator
  3. * Significant concurrent medical condition or other circumstances that may affect the participant s ability to tolerate or complete the study, such as concurrent chemotherapy or bleeding disorders.
  4. * Specific only to the immune checkpoint inhibitor patients, oral cancer as a serious concurrent medical condition, will not serve as an exclusion criteria.
  5. * Moreover, these immune checkpoint inhibitor subjects, if unable to tolerate the study procedures, such as salivary gland biopsies, saliva collections, and/or oral exams, will be excluded as determined by the Principal Investigator.
  6. * Additional exclusion criteria for Healthy Volunteers (HV):
  7. * Pregnancy
  8. * Sicca Symptoms
  9. * HIV, hepatitis B or C infection
  10. * Chronic medical illness, other than well-controlled hypertension or hyperlipidemia
  11. * Chronic use of medications, with the exception of oral contraception, hormone replacement therapy, aspirin, antihypertensives and antilipemics

Contacts and Locations

Study Contact

Eileen M Pelayo
CONTACT
(301) 594-3097
eileen.pelayo@nih.gov
Margaret E Beach, P.A.-C
CONTACT
(301) 451-3479
margaret.beach@nih.gov

Principal Investigator

Margaret E Beach, P.A.-C
PRINCIPAL_INVESTIGATOR
National Institute of Dental and Craniofacial Research (NIDCR)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Dental and Craniofacial Research (NIDCR)

  • Margaret E Beach, P.A.-C, PRINCIPAL_INVESTIGATOR, National Institute of Dental and Craniofacial Research (NIDCR)

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 Date2015-04-03
Study Completion Date2032-04-01

Study Record Updates

Study Start Date2015-04-03
Study Completion Date2032-04-01

Terms related to this study

Keywords Provided by Researchers

  • Genetics
  • Dry Mouth
  • Sjogren's Syndrome
  • Gland dysfunction
  • Induced Pluripotent Stem (iPS) Cell Lines

Additional Relevant MeSH Terms

  • Healthy Volunteer
  • Sjogren's Syndrome
  • Salivary Gland Disease