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OpenTrials
Completed

NCT Number: NCT06040008

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centogene GmbH

Rostock, Mecklenburg-Vorpommern, 18055, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood collection

Genetic
  • 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

Primary outcomes

  1. study the impact of environmental changes in blood transcriptomics

    Time frame: 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 outcomes

  1. different sample collection materials

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

CENTOGENE GmbH Rostock

Industry

Registry information

Official study 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®)

Acronym: IMEN

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 15, 2023
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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