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COLchicine to mitigate accelerated Atherosclerosis induced by immune checkpoint inhibitors in patients with cancer: the COLA trial

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518100-45-00
Enrollment
36
Registered
2025-03-31
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Cancer

Brief summary

Change in maximum target-to-background ratio (TBRmax) in coronary arteries, which quantifies 68Gallium-DOTATATE uptake, between baseline and 12-week follow-up on PET-scan.

Detailed description

TBRmax in carotid arteries, TBRmax in aorta, Mean standardized uptake value (SUVmean) in spleen, SUVmean in bone marrow, Coronary artery calcium score, Major adverse cardiovascular events (i.e. myocardial infarction, ischemic stroke, ischemia-driven coronary revascularisation, death), All-cause mortality, Immune related adverse events, Biomarkers (e.g. blood inflammatory markers, PBMCs, plasma cytokines, metabolomics, and microbiome composition)

Interventions

DRUG-
DRUGCOLCHICINE

Sponsors

Amsterdam UMC Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in maximum target-to-background ratio (TBRmax) in coronary arteries, which quantifies 68Gallium-DOTATATE uptake, between baseline and 12-week follow-up on PET-scan.

Secondary

MeasureTime frame
TBRmax in carotid arteries, TBRmax in aorta, Mean standardized uptake value (SUVmean) in spleen, SUVmean in bone marrow, Coronary artery calcium score, Major adverse cardiovascular events (i.e. myocardial infarction, ischemic stroke, ischemia-driven coronary revascularisation, death), All-cause mortality, Immune related adverse events, Biomarkers (e.g. blood inflammatory markers, PBMCs, plasma cytokines, metabolomics, and microbiome composition)

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026