Understanding diseases that affect salivary glands
Characterization of Diseases With Salivary Gland Involvement
This study is trying to learn more about diseases that affect salivary glands, like Sjogren's Syndrome, by collecting information and samples from people with these conditions and healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1150 (estimated) |
| Ages | 4 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT02327884 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate various diseases that involve salivary glands, such as Sjogren's Syndrome and other salivary gland disorders. It will collect data and biological samples from affected individuals, their relatives, and healthy volunteers to better understand the genetics and pathophysiology of these conditions. Participants will undergo a series of evaluations, including medical history assessments, physical exams, and saliva collection, to determine the causes and severity of salivary gland dysfunction. The findings may provide insights into the impact of these diseases on oral health and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates include individuals over 4 years old with salivary gland disorders, their relatives, and healthy volunteers aged 18 and older.
Not a fit: Patients who are unable to provide consent or are not affected by salivary gland diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of salivary gland diseases, enhancing patient care and quality of life.
How similar studies have performed: While there have been studies on salivary gland diseases, this specific approach focusing on genetic characterization and comprehensive evaluations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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 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. * Specific only to the immune checkpoint inhibitor patients, oral cancer as a serious concurrent medical condition, will not serve as an exclusion criteria. * 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. * Additional exclusion criteria for Healthy Volunteers (HV): * Pregnancy * Sicca Symptoms * HIV, hepatitis B or C infection * 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Margaret E Beach, P.A.-C — National Institute of Dental and Craniofacial Research (NIDCR)
- Study coordinator: Eileen M Pelayo
- Email: eileen.pelayo@nih.gov
- Phone: (301) 594-3097
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.