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InflammationDBS-VBNCT07435285

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

An observational study of Inflammation and Inflammation Biomarkers, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Venous blood sampling and Dried blood spot sampling
How many people
50 participants
Where
1 siteCanada
Study dates
15 Jan 2026to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Adult participants who are planning to receive a seasonal vaccine OR have a scheduled acute stressor

Who may be able to join

  • Men or women aged ≥18 years, who are planning to receive a seasonal vaccine OR have a scheduled acute stressor*.

Who cannot join

  • Any infectious symptoms (fever, cough, rhinorrhea, sore throat, diarrhea, loss of smell or taste) within the previous 7 days
  • Any self-reported active/recent use of cocaine, injection drugs, or amphetamines
  • Acute worsening of a known chronic health condition within the previous 30 days (e.g., of IBD, COPD, asthma, rheumatologic disease)
  • Known severe allergy or intolerance to the planned vaccine
  • Contraindication to the vaccine received, if applicable
  • List of possible scheduled acute stressors include:
Show all 11Show fewer
  • Hard exercise (incl. 10km run or longer, high-intensity interval training, or comparable endurance activity)
  • Social event with moderate alcohol consumption
  • Planned change in medication dose and/or frequency of use
  • Onset of menstruation (day 1)
  • Other pre-planned stressors expected to elicit an inflammatory response

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Evelyn Laferrière, BSc. contact

514-934-1934 ext. 23730

cpau.med@mcgill.ca

Canada1 site, 1 recruiting
  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A 0B1

    Kristen Moran, BSc., 514-934-1934 ext. 23730, cpau.med@mcgill.ca

    Emily G. McDonald, MD MSc

    Recruiting

Other trials in Canada

About this study

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.

Read the 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).

Being tested
Venous blood sampling, Dried blood spot sampling
Keywords
inflammation, blood sampling, biomarkers, inflammatory biomarkers, dried blood spot, paired sampling
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venous blood samplingDiagnostic test

    -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

  • Dried blood spot samplingDiagnostic test

    -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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concordance between inflammatory biomarker concentrations measured in DBS samples and paired venous blood samples

    Agreement and variability between both sample types will be measured using multiple approaches:

    • coefficients of variation
    • intraclass correlation coefficients (ICC)
    • Pearson correlation coefficients
    • Bland-Altman analyses.

    Measured: Enrollment to 3 days after exposure of stressor

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start15 Jan 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07435285
Sponsor's protocol ID
2026-11986
Acronym
DBS-VB
Status last verified
Mar 2026
First submitted
20 Feb 2026
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammation and Inflammation Biomarkers, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristen Moran, BSc. (514-934-1934 ext. x23730, cpau.med@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concordance between inflammatory biomarker concentrations measured in DBS samples and paired venous blood samples (time frame: Enrollment to 3 days after exposure of stressor). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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