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

29. Juli 2026 aktualisiert von: Center for Molecular Fingerprinting Research Nonprofit LLC

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:

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

15000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Center for Molecular Fingerprinting
  • Telefonnummer: +36 30 084 7359
  • E-Mail: info@h4h.hu

Studienorte

  • Ungarn
      • Balatonfüred, Ungarn, 8230
        • Suspendiert
        • 04_DRC Balatonfüred_Drug Research Center LLC
      • Budapest, Ungarn, 1023
        • Rekrutierung
        • 31_TP Szt Magdolna_Trial Pharma Ltd. Magdalene Private Hospital
        • Kontakt:
      • Budapest, Ungarn, 1036
        • Rekrutierung
        • 08_Qualiclinic Budapest_Qualiclinic LLC
        • Kontakt:
          • 08_Qualiclinic Budapest
          • Telefonnummer: +36 80 496 050
          • E-Mail: info@qclinic.hu
      • Budapest, Ungarn, 1062
        • Rekrutierung
        • 22_MÁV Budapest_Railway Health Care Nonprofit Public Benefit Ltd.
        • Kontakt:
      • Budapest, Ungarn, 1085
        • Aktiv, nicht rekrutierend
        • 07_SE Budapest_Semmelweis University, Occupational Health Service
      • Budapest, Ungarn, 1113
        • Suspendiert
        • 01_OVSZ Budapest_Hungarian National Blood Transfusion Service, Central Hungarian Regional Blood Transfusion Center
      • Budapest, Ungarn, 1119
        • Aktiv, nicht rekrutierend
        • 20_TP Budapest_Trial Pharma LLC Budapest
      • Budapest, Ungarn, 1123
        • Rekrutierung
        • 32_OrthoSera_OrthoSera Medical Zrt.
        • Kontakt:
      • Budapest, Ungarn, 1152
        • Aktiv, nicht rekrutierend
        • 11_UNO Med Budapest_UNO MEDICAL TRIALS LLC
      • Budapest, Ungarn, 3527
        • Rekrutierung
        • 23_MÁV Miskolc_Hungarian State Railways Clinic in Miskolc
        • Kontakt:
          • 23_MÁV Miskolc
          • Telefonnummer: +36 46 505 023
          • E-Mail: info@h4h.hu
      • Békéscsaba, Ungarn, 5600
        • Rekrutierung
        • 14_TP Békéscsaba_Trial Pharma LLC Békéscsaba
        • Kontakt:
      • Csorna, Ungarn, 9300
        • Suspendiert
        • 19_TP Csorna_Trial Pharma LLC Csorna
      • Debrecen, Ungarn, 4031
        • Aktiv, nicht rekrutierend
        • 09_Derma-B Debrecen_DERMA-B LLC
      • Debrecen, Ungarn, 4032
        • Aktiv, nicht rekrutierend
        • 05_DE Debrecen_University of Debrecen Clinical Centre, Institute for Primary Care and Health Promotion of Debrecen
      • Encs, Ungarn, 3860
        • Rekrutierung
        • 36_CRU Encs_CRU Hungary Healthcare and Service Provider LLC.
        • Kontakt:
      • Gyula, Ungarn, 5700
        • Rekrutierung
        • 16_TP Gyula_Trial Pharma LLC Gyula
        • Kontakt:
      • Győr, Ungarn, 9026
        • Suspendiert
        • 13_TP Győr_Trial Pharma LLC Győr
      • Hatvan, Ungarn, 3000
        • Rekrutierung
        • 34_BKS Hatvan_BKS Research Ltd. Albert Schweitzer Hospital and Outpatient Clinic
        • Kontakt:
      • Jászszentlászló, Ungarn, 6133
        • Rekrutierung
        • 33_TP Fitt Harmony_Fitt Harmony Ltd
        • Kontakt:
          • 33_TP Fitt Harmony
          • Telefonnummer: +36 20 404 6095
          • E-Mail: info@h4h.hu
      • Kaposvár, Ungarn, 7400
        • Rekrutierung
        • 28_Kaposvár Kh_Somogy County Kaposi Mór Teaching Hospital
        • Kontakt:
          • 28_Kaposvár Kh
          • Telefonnummer: +36 82 501 300
          • E-Mail: korhaz@kmmk.hu
      • Kecskemét, Ungarn, 6000
        • Rekrutierung
        • 30_TP Kék Pont Kecskemét_Blue Point Aquatherapy Ltd. (KomplexLabor site)
        • Kontakt:
      • Kecskemét, Ungarn, 6000
        • Rekrutierung
        • 39_TP Kecskemét_Trial Pharma Ltd. Kecskemét
        • Kontakt:
          • 39_TP Kecskemét
          • Telefonnummer: +36 20 404 6095
          • E-Mail: info@h4h.hu
      • Miskolc, Ungarn, 3526
        • Rekrutierung
        • 26_BAZ Miskolc_Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
        • Kontakt:
      • Nyíregyháza, Ungarn, 4400
        • Aktiv, nicht rekrutierend
        • 21_TP Nyíregyháza_Trial Pharma LLC Nyíregyháza
      • Orosháza, Ungarn, 5900
        • Aktiv, nicht rekrutierend
        • 15_TP Orosháza_Trial Pharma LLC Orosháza
      • Orosháza, Ungarn, 5900
        • Rekrutierung
        • 25_DermaMed_DermaMed Research LCC.
        • Kontakt:
      • Pécs, Ungarn, 7621
        • Rekrutierung
        • 38_Ganglion Orvosi Központ Nozologen Kft._Ganglion Medical Center
        • Kontakt:
          • 38_Ganglion Orvosi Központ Nozologen Kft
          • Telefonnummer: +36 30 539 2825
          • E-Mail: info@ganglion.hu
      • Pécs, Ungarn, 7624
        • Aktiv, nicht rekrutierend
        • 02_PTE Pécs_University of Pécs, Centre for Occupational Health and Hygiene of the University of Pécs Clinical Centre
      • Sopron, Ungarn, 9400
        • Rekrutierung
        • 18_TP Sopron_Trial Pharma LLC Sopron
        • Kontakt:
      • Szeged, Ungarn, 6724
        • Rekrutierung
        • 37_KomplexLabor_KomplexLabor Diagnostics Ltd.
        • Kontakt:
      • Szeged, Ungarn, 6726
        • Rekrutierung
        • 17_TP Szeged_Trial Pharma LLC Szeged
        • Kontakt:
      • Szeged, Ungarn, 6726
        • Rekrutierung
        • 24_MÁV_Szeged_Hungarian State Railways Clinic in Szeged
        • Kontakt:
          • 24_MÁV_Szeged
          • Telefonnummer: +36 62 548 055
          • E-Mail: info@h4h.hu
      • Székesfehérvár, Ungarn, 8000
        • Rekrutierung
        • 03_VVM Veszprém_Vita Verum Medical LLP
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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

Beschreibung

Low- and Moderate-risk Cohort:

Inclusion Criteria:

  1. Signed informed consent form (ICF) of the study.
  2. Age > 40 years.
  3. Willingness to fill in the study questionnaire.
  4. 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.
  5. Willingness to participate in future visits.

Exclusion Criteria:

  1. Self-reported pregnancy (no test).
  2. Indications of clinically relevant medical conditions in self-reported healthy subjects.
  3. 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.
  4. Any conditions preventing blood-draw.
  5. Vulnerable subjects.
  6. Foreseeable lack of compliance.
  7. Participation in another sample collection project of the same sponsor, in order to avoid double evaluation of the same subject.
  8. 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.
  9. Vaccination within the last 14 days.

High-risk Cohort:

Inclusion Criteria:

  1. Signed informed consent form (ICF) of the study.
  2. Age > 50 years.
  3. Willingness to fill in the study questionnaire.
  4. 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):
  5. Hypertension, receiving antihypertensive treatment.
  6. Dyslipidemia/ Hypercholesterolemia (>5.2mmol/L total cholesterol level), on or not on statin-treatment.
  7. 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.
  8. 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.

Exclusion Criteria:

  1. Self-reported pregnancy (no test).
  2. 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).
  3. Interstitial lung disease or severe COPD (chronic obstructive pulmonary disease) in GOLD stages 3 or 4.
  4. Active cancer or malignant disease with less than 5 years history of remission.
  5. 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).
  6. 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.
  7. Any conditions preventing blood-draw or CT scans.
  8. Vulnerable subjects.
  9. Foreseeable lack of compliance.
  10. 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.
  11. 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.
  12. Vaccination within the last 14 days of sample collection.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
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)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Healthy aging
Zeitfenster: 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.
10 years
Coronary artery disease
Zeitfenster: 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.
10 years
Lung cancer
Zeitfenster: 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.
10 years
Type 2 Diabetes
Zeitfenster: 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.
10 years

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Molecular fingerprints
Zeitfenster: 10 years
Molecular fingerprints acquired from plasma samples.
10 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Center for Molecular Fingerprinting Research Nonprofit LLC

Mitarbeiter

Ludwig-Maximilians - University of Munich
Technical University of Munich
Helmholtz Zentrum München
Szeged University
Max Planck Institute of Biochemistry

Ermittler

  • Hauptermittler: Ferenc Krausz, Prof, PhD, Center for Molecular Fingerprinting Research Nonprofit LLC
  • Hauptermittler: Domokos Gerő, MD, PhD, Center for Molecular Fingerprinting Research Nonprofit LLC

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Juli 2021

Primärer Abschluss (Geschätzt)

31. Dezember 2030

Studienabschluss (Geschätzt)

31. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

29. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

29. Juli 2026

Zuerst gepostet (Tatsächlich)

3. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

3. August 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • H4H_HU_2020_Sample Collection

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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