Clinical Study on Healthy Volunteers for Validating the Stability of Different Diagnostic Biomarkers Studied at Firalis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- lncRNA Biomarker expression after breakfast intake
研究概览
简要总结
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
详细描述
Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests measure in blood and other peripheral body fluids; long non-coding RNAs (lncRNAs), small non-coding RNAs (sncRNAs), messenger RNAs (mRNAs), circulating proteins, lipids and metabolites. In addition, since 2020, Firalis is producing the salivary test EasyCOV for detection of Covid-19 positivity in both symptomatic and asymptomatic subjects. Firalis group is the sponsor of a pipeline of various clinical studies conducted in diverse National and European clinical sites of excellence, enrolling patients affected by the targeted diseases studied such as acute myocardial injury, Alzheimer disease for the proof of performance phase of the biomarkers and IVD test candidates. The present specific study aims to collect biological samples to complete the analytical validation of its diverse IVD tools namely the evaluation of the stability of the biomarkers and the effect of age, gender, nutrition and inter-period on the expression level of the studied biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Healthy Volunteers
Healthy Volunteers will be recruited into the study
干预措施: Biomarker based IVD tests (Diagnostic Test)
结局指标
主要结局
lncRNA Biomarker expression after breakfast intake
时间窗: T1- 1 hour after breakfast
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
lncRNA Biomarker expression before breakfast intake
时间窗: T0- Baseline in the morning before breakfast at fasting conditions
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
次要结局
- mRNAs Biomarker expression after breakfast intake(T1- 1 hour after breakfast)
- sncRNA Biomarker expression before breakfast intake(T0- Baseline in the morning before breakfast at fasting conditions)
- mRNAs 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)
- Soluble proteins Biomarker expression before breakfast intake(T0- Baseline in the morning before breakfast at fasting conditions)
- Soluble proteins Biomarker expression after breakfast intake(T1- 1 hour after breakfast)