Characterization of Diseases With Salivary Gland Involvement

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 100
Healthy Volunteers: t
View:

• 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.

⁃ Or,

⁃ \- Persons 18 years or older with active hepatitis with or without sicca symptoms and patients undergoing immunotherapy with an immune checkpoint inhibitor for oral cancer.

⁃ Specific to patients undergoing immunotherapy with an immune checkpoint inhibitor for threatment of oral cancer, these patients will be seen before and after check point inhibitor therapy which will coincide with 4 weeks (+/-2 weeks) before and again immediately before (+/- 2 weeks) definitive oral cancer treatment initiation (e.g., surgical resection, etc.).

⁃ Or,

⁃ \- Healthy persons age 18 or older, who agree to have blood, urine, saliva or tissue samples collected and studied.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Eileen M Pelayo
eileen.pelayo@nih.gov
(301) 594-3097
Backup
Margaret E Beach, P.A.-C
margaret.beach@nih.gov
(301) 451-3479
Time Frame
Start Date: 2015-04-03
Estimated Completion Date: 2032-04-01
Participants
Target number of participants: 1150
Treatments
Group 1
Healthy Volunteers matched with Sjogren's Syndrome patients
Group 2
Family Members, affected and unaffected
Group 3
any other cause salivary gland dysfunction
Authors
Ilias G Alevizos
Sponsors
Leads: National Institute of Dental and Craniofacial Research (NIDCR)

This content was sourced from clinicaltrials.gov