Clinical trial NCT06040008: Investigating the Impact of Environmental Factors on the Transcriptomics Profile in Healthy Individuals
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Lead sponsor: CENTOGENE GmbH Rostock
Sponsor class: INDUSTRY
First posted: 2023-09-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy participants

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: study the impact of environmental changes in blood transcriptomics
timeFrame: 12 months
Secondary outcomes:
measure: different sample collection materials
timeFrame: 12 months
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: Centogene GmbH
state: MV
Study officials:
affiliation: CENTOGENE GmbH Rostock
name: Tobias Böttcher, MD
role: PRINCIPAL_INVESTIGATOR
References: