Recruiting

Observational Study

Sponsor:

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

Code:

NCT07435285

Conditions

Inflammation

Inflammation Biomarkers

Blood Sampling

Dried Blood Spot

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Venous blood sampling

Dried blood spot sampling

Study Details

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

Study ID

NCT07435285

Start date

Jan 15, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

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.

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 ]

Central Contacts and Locations

Central contacts

Kristen Moran, BSc.

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

Evelyn Laferrière, BSc.

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

Locations

Research Institute of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 0B1

Contacts

Kristen Moran, BSc.

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

Principal Investigator:

Emily G. McDonald, MD MSc

More Information

Sponsor

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

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-03-27.