NCT05160337

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
11mo left

Started Jun 2025

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jun 2025Apr 2027

First Submitted

Initial submission to the registry

November 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
3.5 years until next milestone

Study Start

First participant enrolled

June 18, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

July 25, 2025

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

November 8, 2021

Last Update Submit

July 24, 2025

Conditions

Healthy

Keywords

biomarkerschronobiologyhealthy volounteersdiagnostic biomarkers

Outcome Measures

Primary Outcomes (2)

  • lncRNA Biomarker expression before breakfast intake

    lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples

    T0- Baseline in the morning before breakfast at fasting conditions

  • lncRNA Biomarker expression after breakfast intake

    lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples

    T1- 1 hour after breakfast

Secondary Outcomes (6)

  • sncRNA Biomarker expression before breakfast intake

    T0- Baseline in the morning before breakfast at fasting conditions

  • sncRNA Biomarker expression after breakfast intake

    T1- 1 hour after breakfast

  • mRNAs Biomarker expression before breakfast intake

    T0- Baseline in the morning before breakfast at fasting conditions

  • mRNAs Biomarker expression after breakfast intake

    T1- 1 hour after breakfast

  • Soluble proteins Biomarker expression before breakfast intake

    T0- Baseline in the morning before breakfast at fasting conditions

  • +1 more secondary outcomes

Study Arms (1)

Healthy Volunteers

OTHER

Healthy Volunteers will be recruited into the study

Diagnostic Test: Biomarker based IVD tests

Interventions

Biomarker based IVD testsDIAGNOSTIC_TEST

Biomarker based IVD tests

Healthy Volunteers

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firalis Clinical Investigation Center

Huningue, 68330, France

RECRUITING

Study Officials

  • Pierre Rohrlich, MD,Phd

    Firalis SA

    PRINCIPAL INVESTIGATOR

  • Hueseyin Firat, MD, PhD, HDR

    Firalis SA

    STUDY DIRECTOR

  • Stephanie Boutillier, PhD

    Firalis SA

    STUDY CHAIR

Central Study Contacts

Federica ZILLI, PhD

CONTACT

0389911320clinical@firalis.com

Hueseyin Firat, MD, PhD, HDR

CONTACT

0389911320clinical@firalis.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2021

First Posted

December 16, 2021

Study Start

June 18, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

July 25, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)