Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06536075
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Functional Analysis of Salivary Glands and Correlation With Sialoscintigraphy in Sjogrens Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Functional Analysis and Antigen Presentation in Striated Ductal Cells of Salivary Glands and Correlation With Sialoscintigraphy in Patients and Animal Models of Sjogrens Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sjögrens syndrome is a complex autoimmune disorder The investigators hypothesize that striated ductal cells may function as non-professional antigen-presenting cells in Sjögrens 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 Sjögrens 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 Sjögrens syndrome The outcomes will help further applications of sialoscintigraphy in Sjögrens syndrome and formulate hypotheses to explore the pathological mechanisms underlying Sjögrens syndrome
Detailed Description:
Sjögrens 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 Sjögrens 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 Sjögrens 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 Sjögrens syndrome The outcomes will help further applications of sialoscintigraphy in Sjögrens syndrome and formulate hypotheses to explore the pathological mechanisms underlying Sjögrens 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 Sjögrens 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 Sjögrens syndrome and contribute to the development of innovative therapies
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