Assesment of Multiomics Profiles in Health and Disease.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample analysis, Health status, Race and ethnicity.
- Who it may be relevant to
- Registry conditions: Genetic Predisposition to Disease. Basic parameters: 18 years — 68 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assesment of Multiomics Profiles in Health and Disease - Corelation With the Disease Phenotype.
Overview
This study will determine reference genomic, transcriptomic, proteomic and metabolomic profiles in Czech population and will evaluate its correlation with the disease phenotype.
Detailed description
This study will determine reference genomic, transcriptomic, proteomic and metabolomic profiles in Czech population. Initially, there will be 1000 healthy volunteers, with the planned expansion to 10.000 participants (healthy volunteers and patients with different types of disease). Formation of the reference database of healthy volunteers and their parameters will allow a correct interpretation of the potential pathological findings in patients. It is very important to obtain healthy controls from the region of the Czech Republic, Central Europe respectively; since it is not possible to reliably compere ethnically and geographically diverse populations, which have generated in a different context and where the diseases manifest with other etiology ad phenotype. Although, in the limited measure, the similar molecular data exist in foreign databases, these are not compiled from the inhabitants of the Czech Republic, Central Europe not even from Slavic population. Study participants may volunteer for archiving of remaining biological materials for future studies.
Interventions
- Genetic Blood sample analysis
Nucleic acids sequencing, presence of proteins and metabolites. - Other Health status
Health status will be examined by a physician and subject will complete a health status questionnaire. - Other Race and ethnicity
Subject will complete race and ethnicity questionnaire to make sure subjects are from the Czech population.
Primary outcome measures
- Whole Genome (Exom) Sequencing of the Healthy Volunteers - establishment of the HEALTHY VOLUNTEER REFERENCE GENOME (min. 1000 individuals) [Time frame: 72 months]
- Whole Genome (Exom) Sequencing of the patient groups with different diseases and their comparison to the HEALTHY VOLUNTEER REFERENCE GENOME [Time frame: 72 months]
Secondary outcome measures (1)
- Evaluation of the correlation with the disease phenotype [Time frame: 72 months]
Eligibility criteria
Inclusion criteria
- age 18 - 68 years
- (for the first 1100 subjects):
- healthy volunteers without genetically dependent disease and without such a disease in a family
- healthy volunteer without the preliminary evidence of civilizational diseases such as hypertension, diabetes, autoimmune and tumor diseases or acute infectional diseases; clinically manifesting cardiovascular or pulmonary disability.
- subject without permanent of long-term medication in the time of biological sampling.
Exclusion criteria
- not complying with inclusion criteria
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Czechia · 1 center
- University Hospital Olomouc — Olomouc
Identifiers
NCT: NCT04427163 · 302