NCT04427163

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Sep 2018Mar 2029

Study Start

First participant enrolled

September 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

10 years

First QC Date

April 16, 2020

Last Update Submit

February 11, 2026

Conditions

Keywords

genomic profiledisease phenotypeproteomic profilemetabolomic profiletranscriptomic profile

Outcome Measures

Primary Outcomes (2)

  • Whole Genome (Exom) Sequencing of the Healthy Volunteers - establishment of the HEALTHY VOLUNTEER REFERENCE GENOME (min. 1000 individuals)

    Establishment of the Healthy Volunteers Whole Genome (Exom) Reference Database typical for the population of the Czech Republic/Central Europe.

    72 months

  • Whole Genome (Exom) Sequencing of the patient groups with different diseases and their comparison to the HEALTHY VOLUNTEER REFERENCE GENOME

    Whole Genome (Exom) Sequencing of the patient populations presenting various diseases. Based on the comparison with the HEALTHY VOLUNTEER REFERENCE GENOME - determination of various genetic polymorphisms (single nucleotide polymorphisms, insertions, deletions, inversions, copy-number variations etc.) and giving these into correlation with disease phenotypes.

    72 months

Secondary Outcomes (1)

  • Evaluation of the correlation with the disease phenotype

    72 months

Study Arms (1)

Genomic, transcriptomic, proteomic, metabolomic profiles

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

Genetic: Blood sample analysisOther: Health statusOther: Race and ethnicity

Interventions

Nucleic acids sequencing, presence of proteins and metabolites.

Genomic, transcriptomic, proteomic, metabolomic profiles

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

Genomic, transcriptomic, proteomic, metabolomic profiles

Subject will complete race and ethnicity questionnaire to make sure subjects are from the Czech population.

Genomic, transcriptomic, proteomic, metabolomic profiles

Eligibility Criteria

Age18 Years - 68 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Selection from the blood donnors from the blood transfusion department.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Olomouc

Olomouc, Czechia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Genetic Predisposition to Disease

Interventions

Health Statusalpha-methylacyl-CoA racemaseEthnicity

Condition Hierarchy (Ancestors)

Disease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Marian Hajduch, MD, PhD.

    IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry

    STUDY DIRECTOR

Central Study Contacts

Marian Hajduch, MD, PhD.

CONTACT

Michaela Bendova, MSc.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

June 11, 2020

Study Start

September 1, 2018

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

March 30, 2029

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations