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Characterization of Diseases With Salivary Gland Involvement

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ClinicalTrials.gov Identifier: NCT02327884
Recruitment Status : Recruiting
First Posted : December 31, 2014
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

Tracking Information
First Submitted Date December 30, 2014
First Posted Date December 31, 2014
Last Update Posted Date April 24, 2019
Study Start Date December 30, 2014
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 30, 2014)
Hypothesis generating [ Time Frame: Ongoing ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02327884 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterization of Diseases With Salivary Gland Involvement
Official Title Characterization of Diseases With Salivary Gland Involvement
Brief 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
Detailed 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 Sj(SqrRoot)(Delta)gren 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Healthy Volunteer
  • Sjorgren's Syndrome
  • Salivary Gland Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 24, 2018)
1150
Original Estimated Enrollment
 (submitted: December 30, 2014)
320
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • 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 siccasymptoms.

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
  • 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):

    1. Pregnancy
    2. Sicca Symptoms
    3. HIV, hepatitis B or C infection
    4. Chronic medical illness, other than well-controlled hypertension or hyperlipidemia
    5. Chronic use of medications, with the exception of oral contraception, hormone replacement therapy, aspirin, antihypertensives and antilipemics
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Eileen M Pelayo (301) 594-3097 pelayoem@mail.nih.gov
Contact: Blake M Warner, D.D.S. (301) 496-4486 blake.warner@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02327884
Other Study ID Numbers 150051
15-D-0051
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )
Study Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Collaborators Not Provided
Investigators
Principal Investigator: Blake M Warner, D.D.S. National Institute of Dental and Craniofacial Research (NIDCR)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date August 21, 2018