Functional Analysis of Salivary Glands and Correlation With Sialoscintigraphy in Sjogren's Syndrome

NCT06536075 | Recruiting

• 1 other identifier: 202307135MINB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sjögren's syndrome is a complex autoimmune disorder. The investigators hypothesize that striated ductal cells may function as non-professional antigen-presenting cells in Sjögren's syndrome. However, there are currently no established methods to assess the functional status of striated ductal cells or their relationship with clinical presentations. To address this knowledge gap, the investigators aim to investigate the potential of sialoscintigraphy, a non-invasive imaging technique, to evaluate the functional status of striated ductal cells. The sodium iodide symporter (NIS), predominantly expressed in striated ductal cells, facilitates the transport of technetium-99m, a radiotracer used in sialoscintigraphy. The investigators hypothesize that the expression level of NIS, as evaluated through sialoscintigraphy, may serve as an indicator of striated ductal cell function and potentially correlate with clinical manifestations in Sjögren's syndrome. However, the literature and our preliminary data lead us to hypothesize that age and the specific major salivary gland being evaluated may introduce confounding factors in the interpretation of sialoscintigraphy results. The investigators therefore proposed to 1) establish a nomogram of sialoscintigraphy stratified by age and specific salivary glands. The investigators will recruit healthy volunteers to receive sialoscintigraphy for the nomogram; 2) associate the expression level of NIS in the striated ductal cells from the major salivary glands with sialoscintigraphy, markers of antigen presentation, and disease manifestations of Sjögren's syndrome. The outcomes will help further applications of sialoscintigraphy in Sjögren's syndrome and formulate hypotheses to explore the pathological mechanisms underlying Sjögren's syndrome.

Conditions

Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• Quantitative profiles of sialoscintigraphy, including accumulation velocity and secretion velocity

  For establishment of sialoscintigraphy nomogram

  3 months within enrollment

Study Arms (2)

Sialoscintigraphy (healthy control for nomogram)

OTHER

Healthy population for nomogram of sialoscintigraphy

Radiation: Sialoscintigraphy

Sialoscintigraphy (sicca patients)

OTHER

Patients with sicca symptoms. Data of sialoscintigraphy retrieved from medical records.

Radiation: Sialoscintigraphy

Interventions

Sialoscintigraphy RADIATION

Sialoscintigraphy

Sialoscintigraphy (healthy control for nomogram); Sialoscintigraphy (sicca patients)

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nomogram: no sicca symptoms
• Sicca: already receiving sialoscintigraphy

You may not qualify if:

• pregnancy
• breast feeding
• HIV
• cancer with active treatment
• (for nomogram)
• chronic illness needed regular follow-up
• Use anti-histamine, diuretics, anti-depressants, psychotropic medications, anxiolytics or NSAIDs that interfering saliva secretion
• smoking in recent one year
• Positive profiles for anti-SSA or anti-ENA

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• National Taiwan University Hospital

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHIAO-FENG CHENG, MD

CONTACT

0972652625; 103622@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and visiting staff

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 2, 2024
• Study Start: September 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)