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.
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
- Conditions the study is for
- Inflammation, Inflammation Biomarkers, Blood Sampling
- 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.
Canada1 site, 1 recruiting
- 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
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.
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.
- First posted27 Feb 2026
- Study start15 Jan 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sensifai Health
- Responsible party
- Principal investigator, Emily McDonald, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Emily G. McDonald, MD MSc, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Inflammatory Biomarker Changes in Dry Blood Spot Versus Venous Blood Samples
- ClinicalTrials.gov ID
- NCT07435285
- Acronym / sponsor ID
- DBS-VB / 2026-11986
- Keywords
- inflammation, blood sampling, biomarkers, inflammatory biomarkers, dried blood spot, paired sampling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Sensifai Health
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult participants who are planning to receive a seasonal vaccine OR have a scheduled acute stressor
Key inclusion criteria (1 listed)
- Men or women aged ≥18 years, who are planning to receive a seasonal vaccine OR have a scheduled acute stressor*.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | – |
Primary outcome
Concordance between inflammatory biomarker concentrations measured in DBS samples and paired venous blood samples
Time frame: Enrollment to 3 days after exposure of stressor
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily G. McDonald, MD MSc principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
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.