Investigating the Impact of Environmental Factors on the Transcriptomics Profile in Healthy Individuals

Study Overview
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Brief Summary
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Changes in biology will be reflected by changes in the composition of Ribonucleic acid (RNA) in the blood. An example of that would be environmental changes, e.g. diet, acute illness, temperature. The main goal of this study is to study the impact of environmental changes in blood transcriptomics in healthy individuals over time.

Detailed Description
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The project is aiming to evaluate the impact of environmental changes on the blood transcriptome and to assess the feasibility of different sample collection materials for this purpose. Transcriptome from EDTA-DBS. Performing RNAseq from EDTA-DBS, Finger-Prick- DBS and PAXgene RNA tubes has resulted in different levels of analytical background noise. To measure the reflection of this noise, we aim to collect and evaluate blood samples of participating healthy individuals on different time points, to discover how suitable, the DBS is in detecting changes caused by environmental factors (diet, acute disease, temperature). The environmental factors should have variable severity of changes.

Official Title
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Investigating the Impact of Environmental Factors on the Transcriptomics Profile in Healthy Individuals: Comparison of PaxGene RNA Tube and Dried-Blood-Spot Filter Card (CENTOCARD®)

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Genetic: blood collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary, informed consent is obtained from the subject before enrollment in the study The subject is 18 years or older (≥18 years) Healthy participants, as declared by the subject Healthy status is defined by the absence of evidence of any active or chronic disease at the beginning of the study Available to participate for the planned duration of the study for which the screening is being done Exclusion Criteria: • The subject had any clinically significant disease Any clinically relevant history or the presence of e.g., respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, etc. chronic disease Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study A condition in which repeated blood draws poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access In the opinion of the investigator, subject is at high risk of non-compliance and is unsuitable in any other way to participate in this study No informed consent obtained from the subject

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy volunteers<br>Healthy status is defined by the absence of evidence of any active or chronic disease at the beginning of the study | Genetic: blood collection<br>* 3 blood collections over a period of 6 weeks V0 - Inclusion V1 - 3 weeks ± 14 days V2 - 3 weeks ± 14 days 1 EDTA 4 ml tube, 1 PAXgene RNA tube 2,5 ml and drops of blood from finger-prick are taken at each visit Clinical information obtained at each visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| study the impact of environmental changes in blood transcriptomics | Changes in biology will be reflected by changes in the composition of Ribonucleic acid (RNA) in the blood. An example of that would be environmental changes, e.g. diet, acute illness, temperature. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| different sample collection materials | The secondary goal is to evaluate the feasibility of different sample collection materials. RNA collected from PAXgene RNA tubes is a gold standard for RNA extraction from blood. However, CENTOGENE devised an alternative method to obtain RNA from CentoCard® (or Dried-Blood-Spot card/DBS). There is a systematic difference between these methods regarding the extraction and depletion of hemoglobin. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteers