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

CENTOGENE

Status: Completed

Conditions: Healthy Volunteers

Treatments: Genetic: blood collection

Study type: Observational

Funder types: Industry

Identifiers

NCT06040008

IS 01-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 1 patient group

healthy volunteers

Description:

Healthy status is defined by the absence of evidence of any active or chronic disease at the beginning of the study

Treatment:

Genetic: blood collection