Non-communicable Diseases (NCD)H4HNCT07743021
Health for Hungary (H4H) - Longitudinal Collection of Blood Samples and Corresponding Data
An observational study of Non-communicable Diseases (NCD) and Neoplams, run by Center for Molecular Fingerprinting Research Nonprofit LLC at 33 sites in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-communicable Diseases (NCD), Neoplams, Cancer
- How many people
- 15,000 participants
- Where
- 33 sitesHungary
- Study dates
- 27 Jul 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population include healthy participants who are managed by primary healthcare professionals in Hungary, in any parts of the country.
Who may be able to join
- 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.
- Willingness to participate in future visits.
- Signed informed consent form (ICF) of the study.
Show all 13Show fewer
- Age > 50 years.
- Willingness to fill in the study questionnaire.
- Willingness to participate in future visits and medical investigations, the presence of at least 2 of the following 3 risk factors (inclusion criteria #5-7):
- Hypertension, receiving antihypertensive treatment.
- Dyslipidemia/ Hypercholesterolemia (>5.2mmol/L total cholesterol level), on or not on statin-treatment.
- Active or former smoker, with smoking history of at least 20 pack-years, and/or the presence of intermediate lung nodule on prior LDCT testing.
- 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 treatment of the condition is well documented.
Who cannot join
- 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.
- Vulnerable subjects.
- Foreseeable lack of compliance.
Show all 22Show fewer
- Participation in another sample collection project of the same sponsor, in order to avoid double evaluation of the same subject.
- Participation (currently or in the past month) in an early phase clinical trial (phases I and II) involving testing of pharmaceutical products, if the last dose of pharmaceutical product administration was within 30 days of the first sample collection, and / or further pharmaceutical product administration is planned.
- Vaccination within the last 14 days.
- High-risk Cohort:
- Self-reported pregnancy (no test).
- Cardiovascular disease (including obstructive coronary artery disease, peripheral artery disease, aortic aneurysm) or other clinically significant heart disease (congenital, valvular heart disease, cardiomyopathy, heart failure and heart disease requiring ICD [implantable cardioverter defibrillator] or pacemaker therapy).
- Interstitial lung disease or severe COPD (chronic obstructive pulmonary disease) in GOLD stages 3 or 4.
- Active cancer or malignant disease with less than 5 years history of remission.
- Indications of clinically relevant medical conditions in self-reported healthy subjects, especially if (a) the condition requires regular or constant specialist checkups, or (b) pharmacological therapy indicates the presence of significant NCDs or multimorbidity, i.e., chronic polypharmacy (use of 5 or more medications at enrollment or over the last 6 months), or drug therapy necessitating a specialist input for initiation or management (e.g., combined anti-diabetic treatment with two or more medications).
- 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 or CT scans.
- Vulnerable subjects.
- Foreseeable lack of compliance.
- Participation in another sample collection project of the same sponsor, in order to avoid double evaluation of the same subject. 'High-risk' subjects enrolled in the low- and moderate-risk arm of the H4H study might be reallocated to the high-risk study arm after the first 4-5 visits.
- Participation (currently or in the past month) in an early phase clinical trial (phases I and II) involving testing of pharmaceutical products, if the last dose of pharmaceutical product administration was within 30 days of the first sample collection, and/or further pharmaceutical product administration is planned.
- Vaccination within the last 14 days of sample collection.
Trial locations and contacts
33 sites in 1 country. Contact the study team or a site near you to ask about taking part.
33 sites in 1 country
Hungary33 sites, 21 recruiting
- Suspended
04_DRC Balatonfüred_Drug Research Center LLC
Balatonfüred, 8230
- Recruiting
14_TP Békéscsaba_Trial Pharma LLC Békéscsaba
Békéscsaba, 5600
14_TP Békéscsaba, +36 20 398 2923, akiszabo@gportal.hu
- Recruiting
31_TP Szt Magdolna_Trial Pharma Ltd. Magdalene Private Hospital
Budapest, 1023
31_TP Szt Magdolna, +36 1 733 3444, recepcio@szentmagdolna.com
- Recruiting
08_Qualiclinic Budapest_Qualiclinic LLC
Budapest, 1036
08_Qualiclinic Budapest, +36 80 496 050, info@qclinic.hu
- Recruiting
22_MÁV Budapest_Railway Health Care Nonprofit Public Benefit Ltd.
Budapest, 1062
22_MÁV Budapest, +36 1 881 0100, info@vasuteu.hu
- Active, not recruiting
07_SE Budapest_Semmelweis University, Occupational Health Service
Budapest, 1085
- Suspended
01_OVSZ Budapest_Hungarian National Blood Transfusion Service, Central Hungarian Regional Blood Transfusion Center
Budapest, 1113
- Active, not recruiting
20_TP Budapest_Trial Pharma LLC Budapest
Budapest, 1119
- Recruiting
32_OrthoSera_OrthoSera Medical Zrt.
Budapest, 1123
31_OrthoSera, +36 70 770 7298, info@orthosera.com
- Active, not recruiting
11_UNO Med Budapest_UNO MEDICAL TRIALS LLC
Budapest, 1152
- Recruiting
23_MÁV Miskolc_Hungarian State Railways Clinic in Miskolc
Budapest, 3527
23_MÁV Miskolc, +36 46 505 023, info@h4h.hu
- Suspended
19_TP Csorna_Trial Pharma LLC Csorna
Csorna, 9300
- Active, not recruiting
09_Derma-B Debrecen_DERMA-B LLC
Debrecen, 4031
- Active, not recruiting
05_DE Debrecen_University of Debrecen Clinical Centre, Institute for Primary Care and Health Promotion of Debrecen
Debrecen, 4032
- Recruiting
36_CRU Encs_CRU Hungary Healthcare and Service Provider LLC.
Encs, 3860
36_CRU Encs, +36 46 798 262, info@cruint.com
- Suspended
13_TP Győr_Trial Pharma LLC Győr
Győr, 9026
- Recruiting
16_TP Gyula_Trial Pharma LLC Gyula
Gyula, 5700
16_TP Gyula, +36 20 824 4122, akos.szabo@smedical.hu
- Recruiting
34_BKS Hatvan_BKS Research Ltd. Albert Schweitzer Hospital and Outpatient Clinic
Hatvan, 3000
34_BKS Hatvan, +36 37 341 033, korhaz@askhatvan.hu
- Recruiting
33_TP Fitt Harmony_Fitt Harmony Ltd
Jászszentlászló, 6133
33_TP Fitt Harmony, +36 20 404 6095, info@h4h.hu
- Recruiting
28_Kaposvár Kh_Somogy County Kaposi Mór Teaching Hospital
Kaposvár, 7400
28_Kaposvár Kh, +36 82 501 300, korhaz@kmmk.hu
- Recruiting
30_TP Kék Pont Kecskemét_Blue Point Aquatherapy Ltd. (KomplexLabor site)
Kecskemét, 6000
28_TP Kék Pont Kecskemét, +36 30 088 7333, vervetel.info@gmail.com
- Recruiting
39_TP Kecskemét_Trial Pharma Ltd. Kecskemét
Kecskemét, 6000
39_TP Kecskemét, +36 20 404 6095, info@h4h.hu
- Recruiting
26_BAZ Miskolc_Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
Miskolc, 3526
26_BAZ Miskolc, +36 46 515 200 ext. 11846, sajtoreferens@bazmkorhaz.hu
- Active, not recruiting
21_TP Nyíregyháza_Trial Pharma LLC Nyíregyháza
Nyíregyháza, 4400
- Active, not recruiting
15_TP Orosháza_Trial Pharma LLC Orosháza
Orosháza, 5900
- Recruiting
25_DermaMed_DermaMed Research LCC.
Orosháza, 5900
25_DermaMed, +36 30 665 6711, dermamed.research@gmail.com
- Recruiting
38_Ganglion Orvosi Központ Nozologen Kft._Ganglion Medical Center
Pécs, 7621
38_Ganglion Orvosi Központ Nozologen Kft, +36 30 539 2825, info@ganglion.hu
- Active, not recruiting
02_PTE Pécs_University of Pécs, Centre for Occupational Health and Hygiene of the University of Pécs Clinical Centre
Pécs, 7624
- Recruiting
18_TP Sopron_Trial Pharma LLC Sopron
Sopron, 9400
18_TP Sopron, +36 20 960 9400, diag@newmed.hu
- Recruiting
37_KomplexLabor_KomplexLabor Diagnostics Ltd.
Szeged, 6724
37_KomplexLabor, +36 62 770 777, info@komplexlabor.hu
- Recruiting
17_TP Szeged_Trial Pharma LLC Szeged
Szeged, 6726
17_TP Szeged, + 36 305 195 018, h4h2szeged@gmail.com
- Recruiting
24_MÁV_Szeged_Hungarian State Railways Clinic in Szeged
Szeged, 6726
24_MÁV_Szeged, +36 62 548 055, info@h4h.hu
- Recruiting
03_VVM Veszprém_Vita Verum Medical LLP
Székesfehérvár, 8000
03_VVM Veszprém, +36 22 999 555, info@doktorplusz.com
About this study
Official title: Health for Hungary - Longitudinal Collection of Blood Samples and Corresponding Data for Longterm Evaluation of Innovative Diagnostic Techniques in Subjects Without Clinically Relevant Disorders at Baseline to Institute Molecular Fingerprinting Reference Norms
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:
Read more
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.
Read the detailed description
BACKGROUND
The H4H study monitors health changes for 10 years in participants who are healthy at the outset but are at risk to develop new-onset health conditions. It uses a prospective study design and encompasses over 100,000 person-years of follow-up, allowing close observation of disease trajectories in relation to risk factors and medication use. This provides a unique opportunity to collect data on current tendencies in non-communicable disease (NCD) presentation and management.
Major NCDs (i.e., cardiovascular disease, cancer, type 2 diabetes and chronic respiratory disease) cause a significant loss in quality of life and are responsible for over 90 percent of Hungary's all-cause mortality. Therefore, there is growing demand for screening tools that might be used at minimal expense to reduce the overall burden of diseases. 'Early diagnosis' and recognition of high-risk states prior to the development of overt clinical diseases would allow better therapeutic outcomes and help preserve quality of life longer in the society.
Blood tests are valuable screening tools for many conditions and may be used for population health monitoring. Better understanding of blood composition, along with establishing reference ranges for blood constituents, is essential for developing effective blood-based health monitoring strategies.
High-information-content detection methods, including molecular fingerprinting, proteomics and metabolomics are expected to promote the discovery of novel disease biomarkers. By assessing a wide range of molecules, multiple disease-specific variables may be recognized.
Apart from multimodal analysis of blood samples, aliquots of all samples are preserved in a dedicated biobank with a commitment to accommodate a comprehensive collection of biospecimens for decades and to facilitate long-term research arrangements with the intention to accelerate future discoveries.
OBJECTIVES
The study aims to address the following objectives:
- Establish reference ranges for infrared molecular fingerprinting and other high-information-content analysis methods (i.e., proteomics and metabolomics) in a non-symptomatic population using a cross-sectional approach.
- Define characteristics of healthy aging and establish personalized reference intervals for infrared molecular fingerprinting and other high-information-content analysis methods using a longitudinal approach.
- Identify novel biomarkers for non-communicable diseases, including coronary artery disease, lung cancer and diabetes, using infrared molecular fingerprinting and other high-information-content analysis on blood samples.
- Identify novel blood-based risk factors for non-communicable diseases and discover indicators of precursor diseases using infrared molecular fingerprinting and other high-information-content analysis methods.
The findings of the current study will be instrumental in identifying disease specific deviations of human blood composition. This could lead to the discovery of 'novel biomarkers'.
Overall, the study will determine whether the molecular composition of human plasma remains stable over time and will test whether deeper analysis of blood samples can form the basis of population health monitoring.
STUDY DESIGN
The project is conducted in a single-country, multicenter, prospective, longitudinal format. Sample collection is scheduled for ten years according to this protocol.
PARTICIPANTS
The study enrolls healthy subjects of > 40 years or > 50 years in low- or high-risk cohorts, respectively, who are followed up for ten years. Enrollment continues until 15,000 subjects are enrolled.
PROCEDURES:
Blood sample collection occurs in accordance with the clinical routine and plasma samples are processed for high-information-content analysis. Additional blood tubes are submitted to clinical laboratory testing. Health data collection utilizes self-report questionnaires and review of medical records.
In the high-risk cohort, a comprehensive medical examination is performed after the first 4 blood samples are collected, including screening tests for lung cancer and coronary artery disease, i.e., a low-dose CT scan of the chest and coronary artery calcium score test (heart scan). These investigations are repeated after a follow-up period of 5 years.
WITHDRAWAL OF CONSENT, DISCONTINUATION FROM THE STUDY
Participation in this sample and data collection project is voluntary, and each participant has the right to withdraw their consent at any time without any consequence concerning possible future treatment or future blood donations.
- Conditions
- Non-communicable Diseases (NCD), Neoplams, Cancer, Lung Cancer (NSCLC), Cardiovascular Diseases (CVD), Atherosclerotic Cardiovascular Disease (ASCVD)
- Keywords
- Personalized health, Molecular fingerprints, Longitudinal health monitoring, Early-stage disease detection, Innovative research platforms, Precision care, Proteomics, Metabolomics, in vitro diagnostics, Prevention medicine
- Medical subject headings
- Noncommunicable Diseases, Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Cardiovascular Diseases, Atherosclerosis, Peripheral Arterial Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low- and moderate-risk cohort | Apparently healthy, self-reportedly asymptomatic participants aged 40 years or more, who have 0-2 modifiable cardiovascular risk factors (hypertension, hypercholesterolemia, smoking) | |
| High-risk Cohort | Apparently healthy, self-reportedly asymptomatic participants, aged 50 years or more, who have 2(+) modifiable cardiovascular risk factors (hypertension, hypercholesterolemia, smoking) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
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.
Measured: 10 years
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.
Measured: 10 years
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.
Measured: 10 years
Secondary outcomes (1)
Molecular fingerprints
Molecular fingerprints acquired from plasma samples.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start27 Jul 2021
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-communicable Diseases (NCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Molecular Fingerprinting Research Nonprofit LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Szeged University, Ludwig-Maximilians - University of Munich, Max Planck Institute of Biochemistry, Technical University of Munich, Helmholtz Zentrum München
- Responsible party
- Sponsor
- Investigators
- Ferenc Krausz, Prof, PhD, Principal investigator, Center for Molecular Fingerprinting Research Nonprofit LLCDomokos Gerő, MD, PhD, Principal investigator, Center for Molecular Fingerprinting Research Nonprofit LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743021
- Sponsor's protocol ID
- H4H_HU_2020_Sample Collection
- Acronym
- H4H
- Status last verified
- Jul 2026
- First submitted
- 29 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health for Hungary - Longitudinal Collection of Blood Samples and Corresponding Data for Longterm Evaluation of Innovative Diagnostic Techniques in Subjects Without Clinically Relevant Disorders at Baseline to Institute Molecular Fingerprinting Reference Norms
- ClinicalTrials.gov ID
- NCT07743021
- Acronym / sponsor ID
- H4H / H4H_HU_2020_Sample Collection
- Conditions
- Non-communicable Diseases (NCD), Neoplams, Cancer, Lung Cancer (NSCLC), Cardiovascular Diseases (CVD), Atherosclerotic Cardiovascular Disease (ASCVD)
- Keywords
- Personalized health, Molecular fingerprints, Longitudinal health monitoring, Early-stage disease detection, Innovative research platforms, Precision care, Proteomics, Metabolomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Center for Molecular Fingerprinting Research Nonprofit LLCUniversity, hospital or other
- Collaborators
- Szeged University, Ludwig-Maximilians - University of Munich, Max Planck Institute of Biochemistry, Technical University of Munich, Helmholtz Zentrum München
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND
The H4H study monitors health changes for 10 years in participants who are healthy at the outset but are at risk to develop new-onset health conditions. It uses a prospective study design and encompasses over 100,000 person-years of follow-up, allowing close observation of disease trajectories in relation to risk factors and medication use. This provides a unique opportunity to collect data on current tendencies in non-communicable disease (NCD) presentation and management.
Major NCDs (i.e., cardiovascular disease, cancer, type 2 diabetes and chronic respiratory disease) cause a significant loss in quality of life and are responsible for over 90 percent of Hungary's all-cause mortality. Therefore, there is growing demand for screening tools that might be used at minimal expense to reduce the overall burden of diseases. 'Early diagnosis' and recognition of high-risk states prior to the development of overt clinical diseases would allow better therapeutic outcomes and help preserve quality of life longer in the society.
Blood tests are valuable screening tools for many conditions and may be used for population health monitoring. Better understanding of blood composition, along with establishing reference ranges for blood constituents, is essential for developing effective blood-based health monitoring strategies.
High-information-content detection methods, including molecular fingerprinting, proteomics and metabolomics are expected to promote the discovery of novel disease biomarkers. By assessing a wide range of molecules, multiple disease-specific variables may be recognized.
Apart from multimodal analysis of blood samples, aliquots of all samples are preserved in a dedicated biobank with a commitment to accommodate a comprehensive collection of biospecimens for decades and to facilitate long-term research arrangements with the intention to accelerate future discoveries.
OBJECTIVES
The study aims to address the following objectives:
- Establish reference ranges for infrared molecular fingerprinting and other high-information-content analysis methods (i.e., proteomics and metabolomics) in a non-symptomatic population using a cross-sectional approach.
- Define characteristics of healthy aging and establish personalized reference intervals for infrared molecular fingerprinting and other high-information-content analysis methods using a longitudinal approach.
- Identify novel biomarkers for non-communicable diseases, including coronary artery disease, lung cancer and diabetes, using infrared molecular fingerprinting and other high-information-content analysis on blood samples.
- Identify novel blood-based risk factors for non-communicable diseases and discover indicators of precursor diseases using infrared molecular fingerprinting and other high-information-content analysis methods.
The findings of the current study will be instrumental in identifying disease specific deviations of human blood composition. This could lead to the discovery of 'novel biomarkers'.
Overall, the study will determine whether the molecular composition of human plasma remains stable over time and will test whether deeper analysis of blood samples can form the basis of population health monitoring.
STUDY DESIGN
The project is conducted in a single-country, multicenter, prospective, longitudinal format. Sample collection is scheduled for ten years according to this protocol.
PARTICIPANTS
The study enrolls healthy subjects of > 40 years or > 50 years in low- or high-risk cohorts, respectively, who are followed up for ten years. Enrollment continues until 15,000 subjects are enrolled.
PROCEDURES:
Blood sample collection occurs in accordance with the clinical routine and plasma samples are processed for high-information-content analysis. Additional blood tubes are submitted to clinical laboratory testing. Health data collection utilizes self-report questionnaires and review of medical records.
In the high-risk cohort, a comprehensive medical examination is performed after the first 4 blood samples are collected, including screening tests for lung cancer and coronary artery disease, i.e., a low-dose CT scan of the chest and coronary artery calcium score test (heart scan). These investigations are repeated after a follow-up period of 5 years.
WITHDRAWAL OF CONSENT, DISCONTINUATION FROM THE STUDY
Participation in this sample and data collection project is voluntary, and each participant has the right to withdraw their consent at any time without any consequence concerning possible future treatment or future blood donations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low- and moderate-risk cohort | – | –Apparently healthy, self-reportedly asymptomatic participants aged 40 years or more, who have 0-2 modifiable cardiovascular risk factors (hypertension, hypercholesterolemia, smoking) |
| High-risk Cohort | – | –Apparently healthy, self-reportedly asymptomatic participants, aged 50 years or more, who have 2(+) modifiable cardiovascular risk factors (hypertension, hypercholesterolemia, smoking) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population include healthy participants who are managed by primary healthcare professionals in Hungary, in any parts of the country.
Key inclusion criteria (13 listed)
- 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.
- Willingness to participate in future visits.
Key exclusion criteria (22 listed)
- 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.
- Vulnerable subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Healthy aging
Time frame: 10 years
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.
Coronary artery disease
Time frame: 10 years
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.
Lung cancer
Time frame: 10 years
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.
Type 2 Diabetes
Time frame: 10 years
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.
1 secondary outcome
Molecular fingerprints
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- H4H websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ferenc Krausz, Prof, PhD principal investigator
Center for Molecular Fingerprinting Research Nonprofit LLC
Domokos Gerő, MD, PhD principal investigator
Center for Molecular Fingerprinting Research Nonprofit LLC
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-communicable Diseases (NCD) and Neoplams, run by Center for Molecular Fingerprinting Research Nonprofit LLC at 33 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Center for Molecular Fingerprinting (+36 30 084 7359, info@h4h.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy aging (time frame: 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.