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Recruiting NCT05160337

Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers

Conditions: Healthy

Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Firalis SA

Location: Firalis Clinical Investigation Center Huningue

Summary

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

Eligibility Criteria

Inclusion Criteria: * Participants who sign the informed consent forms for sample collection and data collection both anonymized and reported in CRF. * Able to comply with all study procedures. * Healthy Volunteers having no apparent disease. * Adults, both genders, aged 18-85 years. * Participants with no apparent motor or mental health abnormality. * Participants having no major disabling mental or physical disability that would require hospitalization. * Body weight above 50 kg if male, above 40 kg if female. Exclusion Criteria: * Any subject who did not sign the Informed Consent form. * Any subject who, in the judgment of the Investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development. * Any subject in the exclusion period of a previous study according to applicable regulations. * Any subject who cannot be contacted in case of emergency. * Any subject who is the Investigator or any sub-investigator, research assistant, study coordinator, or other staff thereof, directly involved in the conduct of the protocol. * Any subject with a disease that, in the judgement of the investigator, would interfere with the conduct of study or harm the safety of volunteer. * Subjects with disabling disease or abnormal health status are excluded. * Subjects aged below 18 years and older than 85 years are excluded. * Pregnant, parturient and nursing women are excluded. * Subjects deprived of their liberty by a judicial or administrative decision, protected adults and vulnerable persons are excluded. * Subjects who are under legal protection or who are unable to express their consent are not included. * Any subject who reports in the questionnaire of the screening period having one of the following diseases is excluded: * Any psychiatric or neurodegenerative disease or neurologic disorder. * Hypertension. * Any cardiovascular disease. * Any chronic inflammatory disease such as rheumatoid arthritis. * Any cancer. * Frequent headaches and/or migraine, recurrent nausea and/or vomiting. * Any subject who did a blood donation, any volume, within 2 months before inclusion. * Any subject who reports in the questionnaire of the screening period having medication(s) for one or more of the above diseases is excluded. * Drug or alcohol abuse or smoking more than 10 cigarettes or equivalent. * Subjects with no apparent disease and symptoms, but with unknown Covid-19 positivity are not excluded.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05160337). StuddyBuddy aggregates publicly available trial information.