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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04427163




Registration number
NCT04427163
Ethics application status
Date submitted
16/04/2020
Date registered
11/06/2020
Date last updated
1/10/2024

Titles & IDs
Public title
Assesment of Multiomics Profiles in Health and Disease.
Scientific title
Assesment of Multiomics Profiles in Health and Disease - Corelation with the Disease Phenotype.
Secondary ID [1] 0 0
302
Universal Trial Number (UTN)
Trial acronym
ENIGMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Genetic Predisposition to Disease 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Other - Blood sample analysis
Other interventions - Health status
Other interventions - Race and ethnicity

Genomic, transcriptomic, proteomic, metabolomic profiles - Determination of genomic, transcriptomic, proteomic, metabolomic profiles in subjects.


Treatment: Other: Blood sample analysis
Nucleic acids sequencing, presence of proteins and metabolites.

Other interventions: Health status
Health status will be examined by a physician and subject will complete a health status questionnaire.

Other interventions: Race and ethnicity
Subject will complete race and ethnicity questionnaire to make sure subjects are from the Czech population.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Whole Genome (Exom) Sequencing of the Healthy Volunteers - establishment of the HEALTHY VOLUNTEER REFERENCE GENOME (min. 1000 individuals)
Timepoint [1] 0 0
72 months
Primary outcome [2] 0 0
Whole Genome (Exom) Sequencing of the patient groups with different diseases and their comparison to the HEALTHY VOLUNTEER REFERENCE GENOME
Timepoint [2] 0 0
72 months
Secondary outcome [1] 0 0
Evaluation of the correlation with the disease phenotype
Timepoint [1] 0 0
72 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
68 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* not complying with inclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/03/2029
Actual
Sample size
Target
1100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Olomouc

Funding & Sponsors
Primary sponsor type
Other
Name
The Institute of Molecular and Translational Medicine, Czech Republic
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will determine reference genomic, transcriptomic, proteomic and metabolomic profiles in Czech population and will evaluate its correlation with the disease phenotype.
Trial website
https://clinicaltrials.gov/study/NCT04427163
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Marian Hajduch, MD, PhD.
Address 0 0
IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marian Hajduch, MD, PhD.
Address 0 0
Country 0 0
Phone 0 0
+420585632083
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04427163