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

Healthy Volunteers Clinical Trial

— IMEN  

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®)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06040008
• Other study ID #: IS 01-2023
• Status: Recruiting
• Start date: May 9, 2023
• Est. completion date: April 8, 2025

Study information

• Verified date: September 2023
• Source: CENTOGENE GmbH Rostock
• Contact: Clinical Studies
• Phone: +49 381 80113-400
• Email: imenstudy[@]centogene.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 8, 2025
• Est. primary completion date: April 8, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Germany	Centogene GmbH	Rostock	MV

Sponsors (1)

Lead Sponsor	Collaborator
CENTOGENE GmbH Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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