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Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data

ConditionsNon-communicable Diseases (NCD)NeoplamsCancerLung Cancer (NSCLC)Cardiovascular Diseases (CVD)Atherosclerotic Cardiovascular Disease (ASCVD)Peripheral Artery Disease (PAD)Coronary Artery Disease (CAD)Stroke (CVA) or TIADiabetes Mellitus (DM)Type 2 Diabetes (T2DM)PrediabetesChronic Respiratory DiseasesChronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorCenter for Molecular Fingerprinting Research Nonprofit LLC

About this trial

The Health for Hungary (H4H) study collects blood samples and corresponding health data to investigate healthy aging and health-to-disease transitions in middle-aged and elderly participants.

Indications Studied:

Apparently healthy, symptom-free participants are enrolled and followed up to study the onset of new-onset diseases with special emphasis on non-communicable diseases (NCDs).

Study Design:

Single-country, multicenter, prospective, longitudinal survey.

Objectives:

The study aims to establish reference ranges of blood parameters using routine clinical blood tests and high-information-content methods, including proteomics, metabolomics and the so-called infrared molecular fingerprinting.

The study also aims to identify novel biomarkers of major non-communicable diseases, including atherosclerotic cardiovascular disease, cancer, diabetes and chronic respiratory disease.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Signed informed consent form (ICF) of the study.

Age > 40 years.

Willingness to fill in the study questionnaire.

No clinically relevant symptoms as assessed by the investigator, subjects with existing medical conditions may be eligible given that they are symptom free and that full treatment of the condition is medically confirmed.

Disqualifiers

Self-reported pregnancy (no test).

Indications of clinically relevant medical conditions in self-reported healthy subjects.

Self-reported symptom-free HIV, HCV and HBV infections. If HIV, HBV or HCV serology test is done and any of them are positive, the subject will be considered a screen failure.

Any conditions preventing blood-draw.

Trial population

Study population include healthy participants who are managed by primary healthcare professionals in Hungary, in any parts of the country.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

15,000 Participants
are grouped into 2 trial groups
Group A: Low- and moderate-risk cohort
Group B: High-risk Cohort

Trial outcomes

Primary outcomes

1

Healthy aging

Reference ranges of blood parameters are defined that are associated with healthy aging (participants who do not develop any health conditions during the respective follow-up period). Populational normal ranges are established for the cohort and person-specific reference ranges are explored.

Time frame
10 years
2

Coronary artery disease

Incidence of coronary artery disease is followed up with the aim to identify novel biomarkers of new-onset coronary artery disease based on parameters measured with high information content analytical methods.

Time frame
10 years
3

Lung cancer

Incidence of lung cancer is followed up with the aim to identify novel biomarkers of new-onset lung cancer based on parameters measured with high information content analytical methods.

Time frame
10 years
4

Type 2 Diabetes

Incidence of type 2 diabetes is observed with the aim to identify novel biomarkers of new-onset diabetes based on parameters measured with high information content analytical methods.

Time frame
10 years

Secondary outcomes

1

Molecular fingerprints

Molecular fingerprints acquired from plasma samples.

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for Molecular Fingerprinting Research Nonprofit LLC

Lead sponsor

Szeged University

Collaborator

Ludwig-Maximilians - University of Munich

Collaborator

Max Planck Institute of Biochemistry

Collaborator

Technical University of Munich

Collaborator

Helmholtz Zentrum München

Collaborator

Source ClinicalTrials.gov
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