Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
Healthy Volunteers
NCT05160337

Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

Led by Firalis SA · Updated on 2025-07-25

60

Participants Needed

1

Research Sites

93 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level

CONDITIONS

Official Title

Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

Who Can Participate

Age: 18Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants who sign the informed consent forms for sample and data collection
  • Able to comply with all study procedures
  • Healthy volunteers with no apparent disease
  • Adults of any gender aged 18 to 85 years
  • No apparent motor or mental health abnormalities
  • No major disabling mental or physical disabilities requiring hospitalization
  • Body weight above 50 kg for males, above 40 kg for females
Not Eligible

You will not qualify if you...

  • Did not sign the informed consent form
  • Likely to be non-compliant or unable to cooperate due to language or mental development issues
  • In exclusion period of a previous study per regulations
  • Cannot be contacted in an emergency
  • Investigator or study staff directly involved in the protocol
  • Diseases interfering with study conduct or safety
  • Disabling disease or abnormal health status
  • Age below 18 or above 85 years
  • Pregnant, parturient, or nursing women
  • Legally protected or unable to give consent
  • Psychiatric, neurodegenerative, neurologic disorders, hypertension, cardiovascular or chronic inflammatory diseases, cancer, frequent headaches/migraines, recurrent nausea/vomiting
  • Blood donation within 2 months before inclusion
  • Medications for excluded diseases
  • Drug or alcohol abuse or smoking more than 10 cigarettes or equivalent
  • Subjects with unknown Covid-19 positivity are not excluded

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Firalis Clinical Investigation Center

Huningue, France, 68330

Actively Recruiting

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Research Team

F

Federica ZILLI, PhD

CONTACT

H

Hueseyin Firat, MD, PhD, HDR

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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