Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460142
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-05
Brief Title:
Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
Sponsor:
University of Bonn
Organization:
University of Bonn
Study Overview
Official Title:
Multimodal Assessment of Biomarkers for Diagnosing Giant Cell Arteritis and Polymyalgia Rheumatica A Comprehensive Analysis of Clinical Laboratory and Imaging Profiles
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GCAIO
Brief Summary:
The GCAIO study is an innovative multimodal research initiative designed to enhance the understanding diagnosis and management of giant cell arteritis GCA and frequently associated polymyalgia rheumatica PMR This longitudinal study aims to dissect the complex immunological landscape and systemic manifestations of these conditions through a combination of diagnostic imaging and detailed immunological profiling
The study focuses on three primary objectives 1 Identifying and analyzing cytokine profiles and immune cell phenotypes employing techniques like flow cytometry enzyme-linked immunosorbent assays ELISA and next-generation sequencing to predict disease activity and therapeutic responses 2 Advancing diagnostic and monitoring capabilities through the application of novel and established imaging technologies including MRI optical coherence tomography angiography OCTA and ultrasound These modalities aim to improve the detection of neuro-ophthalmological cardiac and aortic complications in GCA potentially offering more precise monitoring and earlier diagnosis 3 Enhancing the understanding of PMR within the context of GCA by exploring specific biomarkers and advanced imaging to refine diagnostic accuracy and treatment strategies thus improving patient outcomes
The study focuses on three primary objectives 1 Identifying and analyzing cytokine profiles and immune cell phenotypes employing techniques like flow cytometry enzyme-linked immunosorbent assays ELISA and next-generation sequencing to predict disease activity and therapeutic responses 2 Advancing diagnostic and monitoring capabilities through the application of novel and established imaging technologies including MRI optical coherence tomography angiography OCTA and ultrasound These modalities aim to improve the detection of neuro-ophthalmological cardiac and aortic complications in GCA potentially offering more precise monitoring and earlier diagnosis 3 Enhancing the understanding of PMR within the context of GCA by exploring specific biomarkers and advanced imaging to refine diagnostic accuracy and treatment strategies thus improving patient outcomes
Detailed Description:
GCA is an immune-mediated vasculitis that affects medium and large-sized vessels leading to vascular changes and occlusion due to severe vascular inflammation neoangiogenesis and remodeling GCA has the potential to impact almost any organ Despite advancements in understanding the pathophysiology and clinical manifestations of GCA many aspects of the disease remain unexplored The GCAIO study aims to fill these gaps using an integrative research approach to enhance the diagnosis understanding and management of GCA
The GCAIO study cohort includes patients at their first diagnosis throughout the disease and during recurrent activity facilitating a thorough longitudinal analysis of GCA The research focuses on the complex immunological processes of the disease Techniques such as flow cytometry FACS enzyme-linked immunosorbent assays ELISA and 3-mRNA transcriptome analysis are employed to identify biomarkers that can assess GCA activity track disease progression and predict therapeutic responses particularly for those unresponsive to interleukin IL-6 receptor R inhibitors Additionally the project is pioneering personalized treatment protocols tailored to individual immune profiles by developing a cell-based ex-vivo assay designed to forecast how patients will respond to different disease-modifying anti-rheumatic drugs DMARDs
Alongside the immunological research the project emphasizes improving diagnostic and monitoring techniques through imaging technologies Recent advancements have demonstrated that optimized diagnostics significantly enhance treatment outcomes for GCA patients The planned prospective multimodal imaging aims to investigate potential neuro-ophthalmological cardiac and aortic manifestations during the course of GCA enabling a detailed assessment of the involvement of various structures Established imaging methods such as magnetic resonance imaging MRI optical coherence tomography angiography OCTA and vascular ultrasound are being extended into new areas to evaluate their diagnostic and prognostic merits Furthermore the investigators are exploring innovative diagnostic tools like transorbital ultrasound TOS and contrast-enhanced ultrasound CEUS for their potential as predictive biomarkers facilitating earlier diagnosis and more precise disease monitoring By correlating imaging findings with immunological data our goal is to alter the way GCA is detected and monitored
The inclusion of patients with PMR enhances our understanding of its pathophysiology clinical manifestations and its connection to often-associated GCA The investigators are dedicated to developing new diagnostic criteria and exploring alternative therapeutic approaches for PMR maintenance therapy By identifying alternative clinical laboratory or instrumental diagnostic methods to predict PMR the investigators aim to set new diagnostic standards and deepen our understanding of its pathophysiology and immunological processes
In summary the goal of the GCAIO study is to make substantial contributions to the fields of GCA and PMR by developing innovative diagnostic and therapeutic strategies that improve treatment and quality of life for affected patients The identification of specific biomarkers and the establishment of new diagnostic standards could lead to more precise diagnoses and optimized management of therapy thereby enhancing patient care and reducing the risk of complications and therapy failures
The GCAIO study cohort includes patients at their first diagnosis throughout the disease and during recurrent activity facilitating a thorough longitudinal analysis of GCA The research focuses on the complex immunological processes of the disease Techniques such as flow cytometry FACS enzyme-linked immunosorbent assays ELISA and 3-mRNA transcriptome analysis are employed to identify biomarkers that can assess GCA activity track disease progression and predict therapeutic responses particularly for those unresponsive to interleukin IL-6 receptor R inhibitors Additionally the project is pioneering personalized treatment protocols tailored to individual immune profiles by developing a cell-based ex-vivo assay designed to forecast how patients will respond to different disease-modifying anti-rheumatic drugs DMARDs
Alongside the immunological research the project emphasizes improving diagnostic and monitoring techniques through imaging technologies Recent advancements have demonstrated that optimized diagnostics significantly enhance treatment outcomes for GCA patients The planned prospective multimodal imaging aims to investigate potential neuro-ophthalmological cardiac and aortic manifestations during the course of GCA enabling a detailed assessment of the involvement of various structures Established imaging methods such as magnetic resonance imaging MRI optical coherence tomography angiography OCTA and vascular ultrasound are being extended into new areas to evaluate their diagnostic and prognostic merits Furthermore the investigators are exploring innovative diagnostic tools like transorbital ultrasound TOS and contrast-enhanced ultrasound CEUS for their potential as predictive biomarkers facilitating earlier diagnosis and more precise disease monitoring By correlating imaging findings with immunological data our goal is to alter the way GCA is detected and monitored
The inclusion of patients with PMR enhances our understanding of its pathophysiology clinical manifestations and its connection to often-associated GCA The investigators are dedicated to developing new diagnostic criteria and exploring alternative therapeutic approaches for PMR maintenance therapy By identifying alternative clinical laboratory or instrumental diagnostic methods to predict PMR the investigators aim to set new diagnostic standards and deepen our understanding of its pathophysiology and immunological processes
In summary the goal of the GCAIO study is to make substantial contributions to the fields of GCA and PMR by developing innovative diagnostic and therapeutic strategies that improve treatment and quality of life for affected patients The identification of specific biomarkers and the establishment of new diagnostic standards could lead to more precise diagnoses and optimized management of therapy thereby enhancing patient care and reducing the risk of complications and therapy failures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None