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Sjogren's SyndromeNCT06536075

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

A study testing Sialoscintigraphy in people with Sjogren's Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Sjogren's Syndrome
What is being tested?
Sialoscintigraphy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
1 Sep 2023to 1 Aug 2025
Phase
Interventional
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 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • pregnancy
  • breast feeding
  • HIV
  • cancer with active treatment
  • (for nomogram)
  • chronic illness needed regular follow-up
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

CHIAO-FENG CHENG, MD contact

0972652625

103622@ntuh.gov.tw

Taiwan1 site, 1 recruiting
  • National Taiwan University Hospital

    Taipei, 100

    Chiao-Feng Cheng, MD, 886-972-652-625, 103622@ntuh.gov.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Functional Analysis and Antigen Presentation in Striated Ductal Cells of Salivary Glands and Correlation With Sialoscintigraphy in Patients and Animal Models of Sjogren's Syndrome

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.

Read the detailed description

Sjögren's syndrome is a complex autoimmune disorder characterized by CD4 T lymphocyte infiltration into the salivary glands, leading to impaired glandular function. The mechanisms underlying lymphocyte accumulation and activation in the absence of definitive antigen-presenting cells remain poorly understood. The investigators hypothesize that striated ductal cells, the primary target of lymphocyte invasion, 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. Therefore, to address these hypotheses, our research proposal consists of three aims. First, establishing a nomogram of sialoscintigraphy stratified by age and specific salivary glands. The investigators will recruit healthy volunteers to receive sialoscintigraphy for the nomogram. This nomogram will provide a valuable reference for clinical application and further research in interpreting sialoscintigraphy results. Second, associating 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. Third, evaluating the capability of antigen presentation in striated ductal cells of salivary glands and to identify potential therapeutic targets. The investigators will examine their ability to uptake extracellular substances and validate their antigen-presenting ability using OT-II cells. Additionally, the investigators will perform RNA sequencing to identify potential therapeutic targets and manipulate their expression to evaluate their impact on the activation of OT-II cells. These findings will confirm that the striated ductal cells as non-professional antigen-presenting cells in Sjögren's syndrome and identify potential therapeutic genetic targets. Overall, our proposed research has the potential to utilize available diagnostic methods to evaluate the striated ductal cells, advance the understanding of how the non-professional antigen-presenting cells participate in the pathogenesis of Sjögren's syndrome, and contribute to the development of innovative therapies.

Being tested
Sialoscintigraphy
Medical subject headings
Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SialoscintigraphyRadiation

    Sialoscintigraphy

Study groups in NCT06536075
Study groupRoleWhat they receive
Sialoscintigraphy (healthy control for nomogram)OtherHealthy population for nomogram of sialoscintigraphy
Receives: Radiation: Sialoscintigraphy
Sialoscintigraphy (sicca patients)OtherPatients with sicca symptoms. Data of sialoscintigraphy retrieved from medical records.
Receives: Radiation: Sialoscintigraphy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative profiles of sialoscintigraphy, including accumulation velocity and secretion velocity

    For establishment of sialoscintigraphy nomogram

    Measured: 3 months within enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start1 Sep 2023
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06536075
Sponsor's protocol ID
202307135MINB
Status last verified
Jul 2024
First submitted
31 Jul 2024
Last updated
6 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Sialoscintigraphy in people with Sjogren's Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.

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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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 Taiwan. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact CHIAO-FENG CHENG, MD (0972652625, 103622@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantitative profiles of sialoscintigraphy, including accumulation velocity and secretion velocity (time frame: 3 months within enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 6 Aug 2024.

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