Women Needed for Early Detection of Sjögren’s Disease Study
Thankam Thyvalikakath
Primary Investigator
Brief description of study
This study is looking at finding biomarkers in blood and saliva samples that will help detect the symptoms of Sjrogrens disease earlier than current diagnosis time. Sjögren's disease is an autoimmune disease that affects the mucous membranes and moisture-secreting glands of your eyes and mouth, resulting in decreased tears and saliva.
For this study, we will compare samples from a group of females with pre-Sjögren’s disease conditions (fibromyalgia, joint pain, and fatigue) with samples from females who do not have these conditions.
We are looking for females (biological sex at birth), 30 years of age or older, who either have fibromyalgia, joint pain, or chronic fatigue OR are generally healthy (with no history of these conditions) to participate.
Detailed description of study
You will be asked to attend 6 study visits in total at the IU School of Dentistry in Indianapolis, IN:
(1) You will complete a prescreening questionnaire to determine your eligibility for the study.
(2) If you are eligible and choose to participate, you will attend 2 bi-annual visits (90 min each) every 6 months for 3 years at the IU School of Dentistry in Indianapolis, IN.
(3) During the study visits, you will complete health questionnaires, undergo a mouth assessment for oral dryness. and provide saliva and blood samples.
(4) You will receive $70 for your first study visit and up to $60 for each follow-up visit, for a total of up to $430 if you complete all of the study requirements. You will also receive a summary of your saliva function test and blood test results. A referral to a rheumatologist or oral medicine specialist will be provided, when applicable.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy, Fibromyalgia, Joint pain, Chronic Fatigue Syndrome
-
Age: 30 years or above
-
Gender: Female
Inclusion Criteria
Case group:
• Biological female aged ≥30 years.
• Provide a signed and dated informed consent form.
• Willing to authorize access and retrieve their electronic dental record and/or electronic health record data available through the Indiana Network for Patient Care (INPC), healthcare system or physician's office.
• History of fibromyalgia, joint pain, or chronic fatigue syndrome for one year or longer recorded in the electronic dental/health record as a coded diagnosis or in the clinical notes and/or self-report a history of these conditions.
• Willing to comply with all study procedures and be available for the duration of the study.
• Willing to provide saliva for the battery of biomarker tests.
• Willing to provide blood sample for biomarker tests.
• Willing to attend follow-up review and biospecimen collection.
Control group:
• Biological female at birth aged ≥30 years.
• No history of fibromyalgia, joint pain, or chronic fatigue syndrome for at least one year at the time of recruitment.
• Will provide a signed and dated informed consent form.
• Willing to authorize access and retrieve their electronic dental record and/or electronic health record data available through the INPC, healthcare system or physician's office.
• Willing to comply with all study procedures and be available for the duration of the study.
• Willing to provide saliva for the biomarker tests.
• Willing to provide blood for biomarker tests.
• Willing to report for follow-up review and biospecimen collection.
Exclusion Criteria (all groups):
• Individuals with previously diagnosed SD.
• Current and previous history of oral cancer.
• History of head and neck radiation treatment
• Actively undergoing chemotherapy for any cancer or taking biological therapeutics.
• Currently taking carbonic anhydrase inhibitors
• Currently taking corticosteroids for three months or longer
• Existing diagnosis of systemic lupus erythematosus and rheumatoid arthritis
