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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

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
Trial website
Trial related presentations / publications
Public notes

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
marian.hajduch@upol.cz
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04427163