NCT06040008

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

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®)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: CENTOGENE GmbH Rostock · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
GENETIC	blood collection	* 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

Timeline

• Start date: 2023-05-09
• Primary completion: 2024-02-29
• Completion: 2024-02-29
• First posted: 2023-09-15
• Last updated: 2024-09-20

Locations

1 site across 1 country: Germany