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

Sponsor

CENTOGENE GmbH Rostock (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06040008

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Genetic: blood collection

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 Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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®)

Actual Study Start Date :

May 9, 2023

Anticipated Primary Completion Date :

Apr 8, 2024

Anticipated Study Completion Date :

Apr 8, 2025

Arms and Interventions

Arm	Intervention/Treatment
healthy volunteers Healthy status is defined by the absence of evidence of any active or chronic disease at the beginning of the study	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

Arm

Intervention/Treatment

healthy volunteers

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

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

Outcome Measures

Primary Outcome Measures

study the impact of environmental changes in blood transcriptomics [12 months]
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.

Secondary Outcome Measures

different sample collection materials [12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centogene GmbH	Rostock	MV	Germany	18055

Sponsors and Collaborators

CENTOGENE GmbH Rostock

Investigators

Principal Investigator: Tobias Böttcher, MD, CENTOGENE GmbH Rostock

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CENTOGENE GmbH Rostock

ClinicalTrials.gov Identifier:

NCT06040008

Other Study ID Numbers:

IS 01-2023

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by CENTOGENE GmbH Rostock

Healthy volunteers

Study Results

No Results Posted as of Sep 15, 2023