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

NCT06040008 | Completed

• 1 other identifier: IS 01-2023
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• different sample collection materials

  12 months

Study Arms (1)

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

Interventions

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

healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

healthy participants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CENTOGENE GmbH Rostock: lead

Study Sites (1)

Centogene GmbH

Rostock, Mecklenburg-Vorpommern, 18055, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tobias Böttcher, MD

  CENTOGENE GmbH Rostock

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 15, 2023
• Study Start: May 9, 2023
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)