Salivary Proteins in Disease and Health
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|ClinicalTrials.gov Identifier: NCT00100204|
Recruitment Status : Completed
First Posted : December 24, 2004
Last Update Posted : July 2, 2017
This study will examine saliva samples from healthy volunteers and patients with various diseases to learn more about how disease affects the mouth and salivary glands. It will use a method called salivary proteomics to identify multiple proteins in saliva and discover if there are protein patterns unique to specific diseases. The study will:
- Characterize the salivary proteome in patients with Sjogren's syndrome, graft-versus-host disease, diabetes, sarcoidosis, cystinosis, dental caries, and immunodeficiencies and in patients who have had head and neck radiation
- Evaluate the possible use of salivary proteomics for early diagnosis
- Evaluate the potential use of salivary proteomics for prognosis and treatment
Patients participating in NIH clinical studies who have Sjogren's syndrome, graft-versus-host disease, diabetes, sarcoidosis, cystinosis, dental caries, or an immunodeficiency, or patients undergoing head and neck radiation may be eligible for this study. Candidates are screened with a medical and dental history, head and neck examination, and photographs of any mouth sores or disease. Healthy volunteers also have blood drawn for routine laboratory testing.
Participants have saliva collected from the floor of the mouth, the parotid salivary glands in the cheek, and the submandibular and sublingual salivary glands under the tongue. Patients with certain diseases also provide a urine sample. Saliva samples are collected as follows:
- One time from healthy volunteers and patients with Sjogren's syndrome, diabetes, sarcoidosis, cystinosis and immunodeficiencies
- Five times from patients undergoing stem cell transplant: at baseline before transplant and about 1, 2, 3 and 6 months after transplant.
- Three times from patients undergoing head and neck radiation: at baseline before radiation and at 3 and 6 months after the conclusion of radiation.
|Condition or disease|
|Diabetes Mellitus Sarcoidosis Dental Caries Sjorgren's Syndrome Cystinosis Head and Neck Neoplasms|
|Study Type :||Observational|
|Actual Enrollment :||264 participants|
|Official Title:||Salivary Proteomics in Disease and Health|
|Study Start Date :||December 21, 2004|
|Study Completion Date :||April 19, 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00100204
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|