Status:
COMPLETED
Salivary Proteins in Disease and Health
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Diabetes Mellitus
Sarcoidosis
Eligibility:
All Genders
Brief Summary
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 sal...
Detailed Description
The diagnostic potential of the proteomic methods has been explored by several groups in recent years. Saliva contains many proteins, some of which are altered in various disease states. In this study...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Male and female subjects of all ages and racial groups will be included. The lower age limit will be determined by the ability to cooperate with saliva collection methods: i.e. 6 months to 100 years old.
- Patients will be recruited from current NIH Clinical Center pools or the outside community. Patients must be diagnosed with cystinosis, sarcoidosis, head and neck cancer, Sjogren's syndrome or diabetes by their institute physician. Controls will be recruited from various NIH populations who are generally healthy and without one of the diseases listed above or through the NIH Healthy Volunteer Program.
- Patients with both benign and malignant disease undergoing bone marrow transplant or hematopoeitic stem cell transplant will be eligible. Among patients with malignant disease both solid tumors and leukemias will be included. Patients who can be diagnosed unequivocally with GVHD via biopsy of the affected organ system will be included in the disease group. Patients will be included in control group when GVHD can be reliably excluded.
- For caries studies, we will examine salivary samples already collected from a large twin cohort study in Brazil. These samples were collected from twins and their siblings as part of a study of early childhood caries. Results from that study suggest that genetics has a role in the development of caries. Whole salivary samples have been collected and frozen for further analysis. These samples will be examined for differences in salivary proteins which may be associated with the development of early childhood caries. Samples are coded with a unique numerical identifier with clinical diagnosis for caries, as well as subject age, gender and ethnicity. No other patient information is linked to this identifier to ensure patient confidentiality.
- EXCLUSION CRITERIA:
- Patients receiving autologous HCT or peripheral stem cell transplants.
- Patients unable to cooperate with saliva collection.
- Controls with a medical history or laboratory findings consistent with Sjogren's syndrome, sarcoidosis, diabetes, or generally poor health, or controls taking medications known to alter salivary protein profiles.
Exclusion
Key Trial Info
Start Date :
December 21 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 19 2011
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00100204
Start Date
December 21 2004
End Date
April 19 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892