Salivary Proteins in Disease and Health
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Other Indications, Dental, Endocrine, Nephrology |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Endocrinology, Nephrology / Urology, Oncology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2004 |
| End Date: | April 2011 |
Salivary Proteomics in Disease and Health
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.
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.
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, saliva is to be sampled in patients with head and neck radiation,
diabetes, hematopoietic stem cell transplant, Sjogren's syndrome, cystinuria, methylmalonic
acidemia and other conditions. Various novel analytical and data-processing tools will be
used to infer characteristic salivary protein and salivary analyte signatures of these
disorders. In some cases, these data will be evaluated with data for the oral flora present
in the saliva and plaque of these patient groups and relate the presence and levels of
particular bacteria to the proteomic profile.
recent years. Saliva contains many proteins, some of which are altered in various disease
states. In this study, saliva is to be sampled in patients with head and neck radiation,
diabetes, hematopoietic stem cell transplant, Sjogren's syndrome, cystinuria, methylmalonic
acidemia and other conditions. Various novel analytical and data-processing tools will be
used to infer characteristic salivary protein and salivary analyte signatures of these
disorders. In some cases, these data will be evaluated with data for the oral flora present
in the saliva and plaque of these patient groups and relate the presence and levels of
particular bacteria to the proteomic profile.
- INCLUSION CRITERIA:
1. 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.
2. 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.
3. 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.
4. 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:
1. Patients receiving autologous HCT or peripheral stem cell transplants.
2. Patients unable to cooperate with saliva collection.
3. 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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