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

NCT07435285 | Recruiting

• 1 other identifier: 2026-11986
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation; Inflammation Biomarkers; Blood Sampling; Dried Blood Spot

Keywords

inflammation; blood sampling; biomarkers; inflammatory biomarkers; dried blood spot; paired sampling

Outcome Measures

Primary Outcomes (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.

  Enrollment to 3 days after exposure of stressor

Interventions

Venous blood sampling DIAGNOSTIC_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 sampling DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Sensifai Health: collaborator

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 0B1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Venous blood samples * Dried blood spot samples

MeSH Terms

Conditions

Inflammation

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Emily G. McDonald, MD MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristen Moran, BSc.

CONTACT

514-934-1934; cpau.med@mcgill.ca

Evelyn Laferrière, BSc.

CONTACT

514-934-1934; cpau.med@mcgill.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSc

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CA (1)