Diabetes MellitusNCT00100204
Salivary Proteins in Disease and Health
An observational study of Diabetes Mellitus and Sarcoidosis, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Sarcoidosis, Dental Caries
- How many people
- 264 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2004to 19 Apr 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: 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
Read more
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.
Read the 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, 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.
- Conditions
- Diabetes Mellitus, Sarcoidosis, Dental Caries, Sjorgren's Syndrome, Cystinosis, Head and Neck Neoplasms
- Keywords
- Head and Neck Radiation, Diabetes, Sarcoidosis, Sjogren's Syndrome, Caries, Healthy Volunteer, HV, Saliva Sample
- Medical subject headings
- Diabetes Mellitus, Sarcoidosis, Dental Caries, Cystinosis, Head and Neck Neoplasms, Sjogren's Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2004 (estimated)
- Study start21 Dec 2004
- Study completion19 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100204
- Sponsor's protocol ID
- 050058
- Other IDs
- 05-D-0058
- Status last verified
- 19 Apr 2011
- First submitted
- 23 Dec 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Fusaro VA, Stone JH. Mass spectrometry-based proteomics and analyses of serum: a primer for the clinical investigator. Clin Exp Rheumatol. 2003 Nov-Dec;21(6 Suppl 32):S3-14.
PubMed 14740422Hanash S. Disease proteomics. Nature. 2003 Mar 13;422(6928):226-32. doi: 10.1038/nature01514.
PubMed 12634796Pusch W, Flocco MT, Leung SM, Thiele H, Kostrzewa M. Mass spectrometry-based clinical proteomics. Pharmacogenomics. 2003 Jul;4(4):463-76. doi: 10.1517/phgs.4.4.463.22753.
PubMed 12831324
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salivary Proteomics in Disease and Health
- ClinicalTrials.gov ID
- NCT00100204
- Acronym / sponsor ID
- 050058
- Conditions
- Diabetes Mellitus, Sarcoidosis, Dental Caries, Sjorgren's Syndrome, Cystinosis, Head and Neck Neoplasms
- Keywords
- Head and Neck Radiation, Diabetes, Sarcoidosis, Sjogren's Syndrome, Caries, Healthy Volunteer, HV, Saliva Sample
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- 21 Dec 2004
- Study completion
- 19 Apr 2011
- First posted
- 24 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 14740422Fusaro VA, Stone JH. Mass spectrometry-based proteomics and analyses of serum: a primer for the clinical investigator. Clin Exp Rheumatol. 2003 Nov-Dec;21(6 Suppl 32):S3-14.
- Background: PubMed 12634796Hanash S. Disease proteomics. Nature. 2003 Mar 13;422(6928):226-32. doi: 10.1038/nature01514.
- Background: PubMed 12831324Pusch W, Flocco MT, Leung SM, Thiele H, Kostrzewa M. Mass spectrometry-based clinical proteomics. Pharmacogenomics. 2003 Jul;4(4):463-76. doi: 10.1517/phgs.4.4.463.22753.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Sarcoidosis, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00100204, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.