Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100204
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-12-23
Brief Title:
Salivary Proteins in Disease and Health
Sponsor:
National Institute of Dental and Craniofacial Research NIDCR
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Salivary Proteomics in Disease and Health
Status:
COMPLETED
Status Verified Date:
2011-04-19
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Sjogrens 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 Sjogrens 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 Sjogrens 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
Characterize the salivary proteome in patients with Sjogrens 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 Sjogrens 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 Sjogrens 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
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 saliva is to be sampled in patients with head and neck radiation diabetes hematopoietic stem cell transplant Sjogrens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-D-0058 | None | None | None |