The VGR GCA Cohort: Ultrasound, Biopsy and Biomarkers - Novel Methods for Diagnosis, Monitoring and Prognosis in Giant Cell Arteritis.

NCT07246577 | Recruiting

• 1 other identifier: 2025-02518-01
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

Giant cell arteritis (GCA) is the most common vasculitis in the elderly and is usually treated with long-term corticosteroid therapy. Many patients experience relapses and treatment-related side effects. Current diagnostic and monitoring methods provide limited prognostic information and cannot reliably distinguish active from inactive disease during relapse. This project addresses the clinical need for improved tools to identify patients at high risk of relapse and to develop more effective methods for disease monitoring. The aim is to develop new tools that enable more personalized treatment of GCA. By combining vascular ultrasound with novel blood biomarkers, we seek to predict disease course and relapse risk. The specific objectives are:

• To identify ultrasound and blood biomarkers that can predict long-term disease control.
• To determine which ultrasound parameters and blood biomarkers can distinguish active from inactive disease during treatment.
• To evaluate whether extended vascular ultrasound protocols can improve diagnostic accuracy. The ultimate goal is to establish safe, practical tools for improved diagnosis and follow-up in patients with GCA.

Conditions

Giant Cell Arteritis (GCA)

Keywords

Prospective Studies; Validation Study; Giant Cell Arteritis; Ultrasonography; Biomarkers; Temporal Arteries; Biopsy

Outcome Measures

Primary Outcomes (1)

• Sustained remission

  Defined as achievement of a daily glucocorticoid dose of ≤5 mg after 12 months of standardized treatment according to the treatment protocol recommended by the Swedish Society for Rheumatology. Primary Objective: To determine which ultrasound parameters and novel biomarkers, individually and as a composite measure (intima-media thickness \[IMT\] + morphological neovascularization), have prognostic value for remission and relapse in patients with giant cell arteritis (GCA). Primary Hypotheses: 1a. The composite measure (IMT + morphological neovascularization) predicts remission at 12 months more accurately than each individual parameter or previously established ultrasound metrics. 1b. Clinically applicable threshold values exist for the composite measure and for selected biomarkers that distinguish patients achieving remission from those who do not.

  12 months

Secondary Outcomes (2)

• Relapse

  Up to 12 months

• Final Diagnosis of GCA

  6 months

Study Arms (2)

GCA group

Individuals diagnosed with GCA

Control group

Individuals not diagnosed with GCA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A new cohort will be recruited. Individuals presenting with suspected GCA at Sahlgrenska University Hospital in Gothenburg, Sweden, or at Skaraborg Hospital Skövde, Sweden, will be invited to participate in the study. Diagnostic ultrasound examinations and follow-up assessments will be conducted at Sahlgrenska University Hospital in Gothenburg. After study enrollment, participants diagnosed with GCA will be followed for 12 months, with scheduled visits at 1, 6, and 12 months after initiation of treatment. If clinical relapse of GCA is suspected outside of the scheduled visits, an additional examination will be performed. Participants who are not diagnosed with GCA will be followed up by telephone after 6 months to confirm diagnostic status.

You may qualify if:

• Individuals referred for evaluation due to suspected giant cell arteritis (GCA).
• Ability to provide written informed consent.

You may not qualify if:

• Previous diagnosis of GCA.
• Previous temporal artery biopsy performed as part of prior GCA evaluation.
• Treatment with high-dose corticosteroids (\>7.5 mg/day) for more than two weeks before initiation of the diagnostic work-up.
• Inability to provide informed consent.
• Inability to comply with the study protocol.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska Universitetssjukhuset

Gothenburg, 41345, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples including serum, plasma, whole blood, and tissue (temporal artery biopsy) will be collected.

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Johan Skoog, MD, PhD

CONTACT

+46313421000; johan.l.skoog@vgregion.se

Eva Klingberg, MD, PhD

CONTACT

+46313421000; eva.klingberg@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: IPD and supporting documents will be made available starting 6 months after publication of the primary endpoint results and will remain accessible for 2 years thereafter.
• Access Criteria: De-identified individual participant data and supporting materials will be available to qualified researchers upon reasonable request for purposes of meta-analysis or secondary research consistent with the study objectives. Requests will be reviewed by the principal investigator, and data will be shared through a secure data transfer process following approval.

Locations

SE (1)