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

29 de julho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

15000

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Center for Molecular Fingerprinting
  • Número de telefone: +36 30 084 7359
  • E-mail: info@h4h.hu

Locais de estudo

  • Hungria
      • Balatonfüred, Hungria, 8230
        • Suspenso
        • 04_DRC Balatonfüred_Drug Research Center LLC
      • Budapest, Hungria, 1023
        • Recrutamento
        • 31_TP Szt Magdolna_Trial Pharma Ltd. Magdalene Private Hospital
        • Contato:
      • Budapest, Hungria, 1036
        • Recrutamento
        • 08_Qualiclinic Budapest_Qualiclinic LLC
        • Contato:
          • 08_Qualiclinic Budapest
          • Número de telefone: +36 80 496 050
          • E-mail: info@qclinic.hu
      • Budapest, Hungria, 1062
        • Recrutamento
        • 22_MÁV Budapest_Railway Health Care Nonprofit Public Benefit Ltd.
        • Contato:
          • 22_MÁV Budapest
          • Número de telefone: +36 1 881 0100
          • E-mail: info@vasuteu.hu
      • Budapest, Hungria, 1085
        • Ativo, não recrutando
        • 07_SE Budapest_Semmelweis University, Occupational Health Service
      • Budapest, Hungria, 1113
        • Suspenso
        • 01_OVSZ Budapest_Hungarian National Blood Transfusion Service, Central Hungarian Regional Blood Transfusion Center
      • Budapest, Hungria, 1119
        • Ativo, não recrutando
        • 20_TP Budapest_Trial Pharma LLC Budapest
      • Budapest, Hungria, 1123
        • Recrutamento
        • 32_OrthoSera_OrthoSera Medical Zrt.
        • Contato:
      • Budapest, Hungria, 1152
        • Ativo, não recrutando
        • 11_UNO Med Budapest_UNO MEDICAL TRIALS LLC
      • Budapest, Hungria, 3527
        • Recrutamento
        • 23_MÁV Miskolc_Hungarian State Railways Clinic in Miskolc
        • Contato:
          • 23_MÁV Miskolc
          • Número de telefone: +36 46 505 023
          • E-mail: info@h4h.hu
      • Békéscsaba, Hungria, 5600
        • Recrutamento
        • 14_TP Békéscsaba_Trial Pharma LLC Békéscsaba
        • Contato:
      • Csorna, Hungria, 9300
        • Suspenso
        • 19_TP Csorna_Trial Pharma LLC Csorna
      • Debrecen, Hungria, 4031
        • Ativo, não recrutando
        • 09_Derma-B Debrecen_DERMA-B LLC
      • Debrecen, Hungria, 4032
        • Ativo, não recrutando
        • 05_DE Debrecen_University of Debrecen Clinical Centre, Institute for Primary Care and Health Promotion of Debrecen
      • Encs, Hungria, 3860
        • Recrutamento
        • 36_CRU Encs_CRU Hungary Healthcare and Service Provider LLC.
        • Contato:
      • Gyula, Hungria, 5700
        • Recrutamento
        • 16_TP Gyula_Trial Pharma LLC Gyula
        • Contato:
      • Győr, Hungria, 9026
        • Suspenso
        • 13_TP Győr_Trial Pharma LLC Győr
      • Hatvan, Hungria, 3000
        • Recrutamento
        • 34_BKS Hatvan_BKS Research Ltd. Albert Schweitzer Hospital and Outpatient Clinic
        • Contato:
      • Jászszentlászló, Hungria, 6133
        • Recrutamento
        • 33_TP Fitt Harmony_Fitt Harmony Ltd
        • Contato:
          • 33_TP Fitt Harmony
          • Número de telefone: +36 20 404 6095
          • E-mail: info@h4h.hu
      • Kaposvár, Hungria, 7400
        • Recrutamento
        • 28_Kaposvár Kh_Somogy County Kaposi Mór Teaching Hospital
        • Contato:
          • 28_Kaposvár Kh
          • Número de telefone: +36 82 501 300
          • E-mail: korhaz@kmmk.hu
      • Kecskemét, Hungria, 6000
        • Recrutamento
        • 30_TP Kék Pont Kecskemét_Blue Point Aquatherapy Ltd. (KomplexLabor site)
        • Contato:
      • Kecskemét, Hungria, 6000
        • Recrutamento
        • 39_TP Kecskemét_Trial Pharma Ltd. Kecskemét
        • Contato:
          • 39_TP Kecskemét
          • Número de telefone: +36 20 404 6095
          • E-mail: info@h4h.hu
      • Miskolc, Hungria, 3526
        • Recrutamento
        • 26_BAZ Miskolc_Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
        • Contato:
      • Nyíregyháza, Hungria, 4400
        • Ativo, não recrutando
        • 21_TP Nyíregyháza_Trial Pharma LLC Nyíregyháza
      • Orosháza, Hungria, 5900
        • Ativo, não recrutando
        • 15_TP Orosháza_Trial Pharma LLC Orosháza
      • Orosháza, Hungria, 5900
        • Recrutamento
        • 25_DermaMed_DermaMed Research LCC.
        • Contato:
      • Pécs, Hungria, 7621
        • Recrutamento
        • 38_Ganglion Orvosi Központ Nozologen Kft._Ganglion Medical Center
        • Contato:
          • 38_Ganglion Orvosi Központ Nozologen Kft
          • Número de telefone: +36 30 539 2825
          • E-mail: info@ganglion.hu
      • Pécs, Hungria, 7624
        • Ativo, não recrutando
        • 02_PTE Pécs_University of Pécs, Centre for Occupational Health and Hygiene of the University of Pécs Clinical Centre
      • Sopron, Hungria, 9400
        • Recrutamento
        • 18_TP Sopron_Trial Pharma LLC Sopron
        • Contato:
          • 18_TP Sopron
          • Número de telefone: +36 20 960 9400
          • E-mail: diag@newmed.hu
      • Szeged, Hungria, 6724
        • Recrutamento
        • 37_KomplexLabor_KomplexLabor Diagnostics Ltd.
        • Contato:
      • Szeged, Hungria, 6726
        • Recrutamento
        • 17_TP Szeged_Trial Pharma LLC Szeged
        • Contato:
      • Szeged, Hungria, 6726
        • Recrutamento
        • 24_MÁV_Szeged_Hungarian State Railways Clinic in Szeged
        • Contato:
          • 24_MÁV_Szeged
          • Número de telefone: +36 62 548 055
          • E-mail: info@h4h.hu
      • Székesfehérvár, Hungria, 8000
        • Recrutamento
        • 03_VVM Veszprém_Vita Verum Medical LLP
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
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)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Healthy aging
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Molecular fingerprints
Prazo: 10 years
Molecular fingerprints acquired from plasma samples.
10 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Center for Molecular Fingerprinting Research Nonprofit LLC

Colaboradores

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

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

27 de julho de 2021

Conclusão Primária (Estimado)

31 de dezembro de 2030

Conclusão do estudo (Estimado)

31 de dezembro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

29 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de julho de 2026

Primeira postagem (Real)

3 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • H4H_HU_2020_Sample Collection

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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