NCT07246577 The VGR GCA Cohort: Ultrasound, Biopsy and Biomarkers - Novel Methods for Diagnosis, Monitoring and Prognosis in Giant Cell Arteritis.
| NCT ID | NCT07246577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vastra Gotaland Region |
| Condition | Giant Cell Arteritis (GCA) |
| Study Type | OBSERVATIONAL |
| Enrollment | 340 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2029-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 340 participants in total. It began in 2026-03-01 with a primary completion date of 2029-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria * Individuals referred for evaluation due to suspected giant cell arteritis (GCA). * Ability to provide written informed consent. Exclusion Criteria * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07246577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Giant Cell Arteritis (GCA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07246577 currently recruiting?
Yes, NCT07246577 is actively recruiting participants. Contact the research team at johan.l.skoog@vgregion.se for enrollment information.
Where is the NCT07246577 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT07246577 clinical trial?
NCT07246577 is sponsored by Vastra Gotaland Region. The trial plans to enroll 340 participants.