Characterization of Diseases With Salivary Gland Involvement

  • STATUS
    Recruiting
  • End date
    Apr 1, 2032
  • participants needed
    1150
  • sponsor
    National Institute of Dental and Craniofacial Research (NIDCR)
Updated on 18 June 2022
cancer
cancer treatment
dry eyes
Accepts healthy volunteers

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

Description

This protocol is intended to allow disease-specific investigations in subjects with presentations of diseases with salivary gland involvement and will enable the collection of data, biological fluids and tissue samples from those subjects, their family members and normal controls, in order to assist our studies of understanding salivary gland disease pathophysiology. The exocrine salivary glands, by secreting saliva, play a critical role in the homeostasis of the oral cavity, which is the initial part of the gastrointestinal track. Several diseases including Parkinson s and systemic amyloidosis can be diagnosed through biopsies of easily accessible salivary glands. Moreover, several drugs and systemic diseases cause salivary gland hypofunction through unknown mechanisms.

We may evaluate participants with complaints of dry mouth to determine the cause and severity of their salivary gland dysfunction and their possible eligibility for other NIDCR protocols. Salivary secretions have antibacterial, lubricating, remineralizing, digestive, buffering and cleansing properties. Impaired function of these glands can cause an increase in tooth decay; a variety of oral hard and soft tissue changes, with painful, burning or ulcerated or oral mucosa; problems chewing, swallowing and speaking; and diminished taste and smell.

This protocol will provide us with the opportunity to learn from a variety of pathologies that involve directly or indirectly the salivary glands, expand our knowledge about these disorders and provide access to patients of interest for research, teaching, and clinical experience. Information obtained through this protocol may lead to potential innovative therapeutic studies. In addition to its role in investigating individuals who are of interest to the Sjogren s syndrome (SS) and Salivary Gland Dysfunction Unit of the MPTB of NIDCR, this protocol can provide a possible avenue for enrolling subjects from other NIH programs or other NIH protocols that exhibit signs or symptoms associated with the salivary glands dysfunction.

Details
Condition Healthy Volunteer, Sjogren's Syndrome, Salivary Gland Disease
Clinical Study IdentifierNCT02327884
SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last Modified on18 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Anyone not able to give consent/assent or parental/guardian consent
NIH employees who report directly to the principal investigator
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
Additional exclusion criteria for Healthy Volunteers (HV)
Specific only to the immune checkpoint inhibitor patients, oral cancer as a
Pregnancy
Sicca Symptoms
serious concurrent medical condition, will not serve as an exclusion criteria
HIV, hepatitis B or C infection
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
Chronic medical illness, other than well-controlled hypertension or
hyperlipidemia
Chronic use of medications, with the exception of oral contraception, hormone
replacement therapy, aspirin, antihypertensives and antilipemics
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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