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 6 May 2021
cancer
cancer treatment
dry eyes

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 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.

Details
Condition Salivary Gland Disease, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Healthy Volunteer, Peripheral Arterial Occlusive Disease, Brain Function, Recurrent Respiratory Papillomatosis, Sjorgren's Syndrome, Razor Bumps (Pseudofolliculitis Barbae), Saliva and Salivary Gland Dysfunction, Metastatic Triple-Negative Breast Cancer
Clinical Study IdentifierNCT02327884
SponsorNational Institute of Dental and Craniofacial Research (NIDCR)
Last Modified on6 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Do you have any of these conditions: Vaginal Atrophy or Primary Immunodeficiency or Saliva and Salivary Gland Dysfunction or Chronic Shoulder Pain or Pediatric Health or Anal Dysplasia or...?
Do you have any of these conditions: Injection Port or Salivary Gland Disease or Metastatic Triple-Negative Breast Cancer or Brain Function or Breast Cancer - HER2 Positive or Diet and Nu...?
Do you have any of these conditions: Recurrent Respiratory Papillomatosis or Saliva and Salivary Gland Dysfunction or Metastatic Triple-Negative Breast Cancer or Anal Dysplasia or Diet an...?
Do you have any of these conditions: Breast Cancer - HER2 Positive or Chronic Diarrhea or Sjorgren's Syndrome or Diet and Nutrition or Chronic Shoulder Pain or Razor Bumps (Pseudofollicul...?
Do you have any of these conditions: Diet and Nutrition or Brain Function or Razor Bumps (Pseudofolliculitis Barbae) or Chronic Shoulder Pain or Anal Dysplasia or Sjorgren's Syndrome or S...?
Do you have any of these conditions: Diet and Nutrition or Saliva and Salivary Gland Dysfunction or Brain Function or Salivary Gland Disease or Healthy Volunteer or Metastatic Triple-Nega...?
Do you have any of these conditions: Injection Port or Diet and Nutrition or Metastatic Triple-Negative Breast Cancer or Skin Wounds or Peripheral Arterial Occlusive Disease or Primary Im...?
Do you have any of these conditions: Anal Dysplasia or Peripheral Arterial Occlusive Disease or Recurrent Respiratory Papillomatosis or Razor Bumps (Pseudofolliculitis Barbae) or Vaginal ...?
Do you have any of these conditions: Primary Immunodeficiency or Anal Dysplasia or Breast Cancer - HER2 Positive or Metastatic Triple-Negative Breast Cancer or Chronic Shoulder Pain or Di...?
Do you have any of these conditions: Recurrent Respiratory Papillomatosis or Sjorgren's Syndrome or Pediatric Health or Anal Dysplasia or Healthy Volunteer or Saliva and Salivary Gland Dy...?
Do you have any of these conditions: Skin Wounds or Saliva and Salivary Gland Dysfunction or Adverse Effects, Drugs or Chronic Diarrhea or Recurrent Respiratory Papillomatosis or Salivary...?
Is your age greater than or equal to 4 yrs?
Do you have any of these conditions: Injection Port or Saliva and Salivary Gland Dysfunction or Sjorgren's Syndrome or Salivary Gland Disease or Near-Sighted Corrective Surgery or Breast ...?
Do you have any of these conditions: Brain Function or Breast Cancer - HER2 Positive or Healthy Volunteer or Pediatric Health or Peripheral Arterial Occlusive Disease or Injection Port or...?
Do you have any of these conditions: Metastatic Triple-Negative Breast Cancer or Brain Function or Chronic Shoulder Pain or Diet and Nutrition or Skin Wounds or Near-Sighted Corrective Su...?
Do you have any of these conditions: Primary Immunodeficiency or Recurrent Respiratory Papillomatosis or Diet and Nutrition or Healthy Volunteer or Saliva and Salivary Gland Dysfunction o...?
Do you have any of these conditions: or Vaginal Atrophy or Recurrent Respiratory Papillomatosis or Injection Port or Peripheral Arterial Occlusive Disease or Near-Sighted Corrective Surg...?
Do you have any of these conditions: or Injection Port or Recurrent Respiratory Papillomatosis or Anal Dysplasia or Diet and Nutrition or Pediatric Health or Saliva and Salivary Gland Dy...?
Do you have any of these conditions: or Diet and Nutrition or Skin Wounds or Adverse Effects, Drugs or Recurrent Respiratory Papillomatosis or Anal Dysplasia or Metastatic Triple-Negativ...?
Do you have any of these conditions: or Recurrent Respiratory Papillomatosis or Injection Port or Salivary Gland Disease or Metastatic Triple-Negative Breast Cancer or Chronic Shoulder P...?
Gender: Male or Female
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
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