Characterization of Diseases With Salivary Gland Involvement

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Dental and Craniofacial Research (NIDCR)
Study ID
NCT02327884
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
4 Years - 100 Years
Healthy Volunteers
Accepted

Study Details

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

Key Dates

Start date
Apr 3, 2015
Status verified
May 2026
Primary completion
Apr 1, 2032
Completion
Apr 1, 2032

Study Design

Enrollment
1,150 participants (estimated)

Arms

  • Arm: Group 1
    Healthy Volunteers matched with Sjogren's Syndrome patients
  • Arm: Group 2
    Family Members, affected and unaffected
  • Arm: Group 3
    any other cause salivary gland dysfunction

Primary Outcome Measure

hypothesis generating [ Time Frame: hypothesis generating ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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