An observational study in Non-communicable Diseases (NCD), Neoplams and Cancer, sponsored by Center for Molecular Fingerprinting Research Nonprofit LLC. Recruiting at 33 sites in Hungary. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Center for Molecular Fingerprinting Research Nonprofit LLC · Observational
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.
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:
A) 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.
B) 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.
C) 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.
D) 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.
144 studies on the registry are indexed under Noncommunicable Diseases; 55 are open to participants now.
This study's planned enrollment of 15,000 is above the median of 1,674 across 48 observational studies indexed under Noncommunicable Diseases.
Browse Noncommunicable Diseases studies →This is the only study on the registry with Center for Molecular Fingerprinting Research Nonprofit LLC as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Study population include healthy participants who are managed by primary healthcare professionals in Hungary, in any parts of the country.
Low- and Moderate-risk Cohort:
Inclusion Criteria:
Exclusion Criteria:
High-risk Cohort:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Apparently healthy, self-reportedly asymptomatic participants aged 40 years or more, who have 0-2 modifiable cardiovascular risk factors (hypertension, hypercholesterolemia, smoking)
Apparently healthy, self-reportedly asymptomatic participants, aged 50 years or more, who have 2(+) modifiable cardiovascular risk factors (hypertension, hypercholesterolemia, smoking)
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
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
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
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
Molecular fingerprints
Molecular fingerprints acquired from plasma samples.
Time frame: 10 years
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Plan to share: No
Started Jul 2021 (actual). Primary completion is estimated for Dec 2030, 113 months after the start.
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