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

NCT ID: NCT06040008

Last Updated: 2024-09-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-09
• Study Completion Date: 2024-02-29

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

healthy volunteers

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

blood collection

Intervention Type: 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

Interventions

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

Intervention Type: GENETIC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CENTOGENE GmbH Rostock

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Böttcher, MD

Role: PRINCIPAL_INVESTIGATOR

CENTOGENE GmbH Rostock

Locations

Centogene GmbH

Rostock, Mecklenburg-Vorpommern, Germany

Countries

Germany

Other Identifiers

IS 01-2023

Identifier Type: -

Identifier Source: org_study_id