Investigating the Impact of Environmental Factors on the Transcriptomics Profile in Healthy Individuals (IMEN)
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®)
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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MV
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Rostock, MV, Germany, 18055
- CENTOGENE GmbH
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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healthy volunteers
Healthy status is defined by the absence of evidence of any active or chronic disease at the beginning of the study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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study the impact of environmental changes in blood transcriptomics
Time Frame: 12 months
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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.
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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different sample collection materials
Time Frame: 12 months
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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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tobias Böttcher, MD, CENTOGENE GmbH Rostock
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IS 01-2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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