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

2026년 7월 29일 업데이트: 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.

연구 개요

상태

모병

정황

상세 설명

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.

연구 유형

관찰

등록 (추정된)

15000

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Center for Molecular Fingerprinting
  • 전화번호: +36 30 084 7359
  • 이메일: info@h4h.hu

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

예

샘플링 방법

비확률 샘플

연구 인구

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

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Healthy aging
기간: 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
기간: 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
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Molecular fingerprints
기간: 10 years
Molecular fingerprints acquired from plasma samples.
10 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Center for Molecular Fingerprinting Research Nonprofit LLC

협력자

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

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 7월 27일

기본 완료 (추정된)

2030년 12월 31일

연구 완료 (추정된)

2030년 12월 31일

연구 등록 날짜

최초 제출

2026년 7월 29일

QC 기준을 충족하는 최초 제출

2026년 7월 29일

처음 게시됨 (실제)

2026년 8월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 29일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • H4H_HU_2020_Sample Collection

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다