NCT07435285

Analysis of Inflammatory Biomarker Changes in Dry Blood Spot Versus Venous Blood Samples

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this study is to see whether dried blood spot (DBS) samples can measure inflammatory biomarkers as accurately as venous blood samples. Investigators will be measuring inflammatory biomarkers changes obtained in DBS compared with paired venous blood samples following a controlled physiological stressor (i.e. after a vaccine or other planned event that can cause a temporary rise in inflammation). These findings will help understand whether DBS can be a reliable alternative to traditional blood draws in future research and healthcare.

Detailed description

Inflammation plays a key role in the progression of both acute and chronic health conditions. When properly regulated, inflammatory responses enable the body to adapt to short-term stressors such as infection, vaccination, or strenuous exercise.1 In contrast, excessive and/or prolonged inflammation can lead to the development and progression of chronic health conditions including cardiovascular disease, autoimmune disorders, and metabolic dysfunction.2 In both acute and chronic settings, measuring changes in inflammatory biomarkers allows us to better understand how the immune system responds to physiological challenges, which may ultimately support the development of earlier testing (diagnostic) strategies, more accurate detection methods, and timely interventions for individuals most at risk. Venous blood sampling is the gold standard for measuring inflammatory biomarker concentrations. However, venous blood sampling is invasive, requires trained personnel, and entails a visit to a hospital or health clinic.3 Dependence on venous sampling for inflammatory biomarker detection therefore limits the feasibility of decentralized, real-world investigations, such as those conducted in home environments. This restriction reduces opportunities for longitudinal data collection and poses challenges for larger-scale and/or high temporal frequency sampling protocols. More recently, dried blood spot (DBS) samples have shown to be a compelling alternative to assess inflammatory biomarkers like C-reactive protein (CRP) in the blood. In comparison, this method is minimally invasive, can be obtained by the patient rather than trained personnel, involves fewer requirements for transport and storage, and is less costly than venous blood sampling.3-7 Previous comparative studies between venous blood sampling and DBS, have shown the latter's potential for measuring a wide range of indices, including inflammatory biomarkers during both chronic and acute medical conditions. In fact, numerous studies have shown good concordance between the DBS and venous blood sampling methods, namely for CRP, interleukin (IL)-6, IL-10, and tumor necrosis factor alpha (TNF-α).3,8-13 Furthermore, a recent study by Anderson et al. demonstrated that DBS can reliably capture dynamic changes in 12 inflammatory biomarkers (incl., serum amyloid A (SAA), myeloperoxidase (MPO), immunoglobin M (IgM)) across diverse conditions (infection, vaccination, surgery, exercise, Crohn's disease) and over both acute and chronic timescales; however, these markers have yet to be directly compared to venous blood sample analysis.14 It is not yet well enough established whether inflammatory biomarkers can be measured from DBS with the same quality, sensitivity, and reproducibility as from venous blood samples, while certain gaps remain regarding how DBS performs when capturing acute, stressor-induced fluctuations in circulation concentrations of inflammatory biomarkers. Addressing these gaps is critical to determine whether DBS can serve as a valid substitute for venous blood sampling in research and clinical contexts. Based on these considerations, this study aims to validate the measurement of change in inflammatory biomarkers obtained in DBS compared with paired venous blood samples following a controlled physiological stressor, using a comprehensive (48-plex) inflammatory biomarker panel. The overarching aim of this study is to validate and compare the measurement of changes in inflammatory biomarkers obtained from dried blood spot (DBS) samples against paired venous blood samples, using the Human Cytokine/Chemokine Panel A 48-Plex (HD48A).

Conditions

• Inflammation
• Inflammation Biomarkers
• Blood Sampling
• Dried Blood Spot

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Venous blood sampling	-Venous blood samples (1-2 mL) will be collected into EDTA and serum-separator vacutainer tubes. Samples will be processed within one hour by centrifugation (1,500g, 10 min, 4°C), and plasma/serum aliquots will be stored at -80°C
DIAGNOSTIC_TEST	Dried blood spot sampling	-DBS samples will be collected via finger prick (using a lancet) onto certified filter paper (Dried Blood Spot Sample Collection Kit with Lancets, Salimetrics, LLC; State College, PA, USA). Two blood spots (\~20 µL each) will be dried at room temperature for at least two hours, then stored in a sealed bag at -20°C with desiccant. Validated guidelines for the collection, storage and preparation of DBS samples will be followed to ensure proper quality control.

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-02-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Canada