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

2026年7月29日 更新者：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.

調査の概要

状態

募集

条件

詳細な説明

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.

研究の種類

観察的

入学 (推定)

15000

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Center for Molecular Fingerprinting
  • 電話番号：+36 30 084 7359
  • メール：info@h4h.hu

研究場所

  • ハンガリー
      • Balatonfüred、ハンガリー、8230
        • 一時停止
        • 04_DRC Balatonfüred_Drug Research Center LLC
      • Budapest、ハンガリー、1023
        • 募集
        • 31_TP Szt Magdolna_Trial Pharma Ltd. Magdalene Private Hospital
        • コンタクト：
      • Budapest、ハンガリー、1036
        • 募集
        • 08_Qualiclinic Budapest_Qualiclinic LLC
        • コンタクト：
          • 08_Qualiclinic Budapest
          • 電話番号：+36 80 496 050
          • メール：info@qclinic.hu
      • Budapest、ハンガリー、1062
        • 募集
        • 22_MÁV Budapest_Railway Health Care Nonprofit Public Benefit Ltd.
        • コンタクト：
          • 22_MÁV Budapest
          • 電話番号：+36 1 881 0100
          • メール：info@vasuteu.hu
      • Budapest、ハンガリー、1085
        • 積極的、募集していない
        • 07_SE Budapest_Semmelweis University, Occupational Health Service
      • Budapest、ハンガリー、1113
        • 一時停止
        • 01_OVSZ Budapest_Hungarian National Blood Transfusion Service, Central Hungarian Regional Blood Transfusion Center
      • Budapest、ハンガリー、1119
        • 積極的、募集していない
        • 20_TP Budapest_Trial Pharma LLC Budapest
      • Budapest、ハンガリー、1123
        • 募集
        • 32_OrthoSera_OrthoSera Medical Zrt.
        • コンタクト：
      • Budapest、ハンガリー、1152
        • 積極的、募集していない
        • 11_UNO Med Budapest_UNO MEDICAL TRIALS LLC
      • Budapest、ハンガリー、3527
        • 募集
        • 23_MÁV Miskolc_Hungarian State Railways Clinic in Miskolc
        • コンタクト：
          • 23_MÁV Miskolc
          • 電話番号：+36 46 505 023
          • メール：info@h4h.hu
      • Békéscsaba、ハンガリー、5600
        • 募集
        • 14_TP Békéscsaba_Trial Pharma LLC Békéscsaba
        • コンタクト：
      • Csorna、ハンガリー、9300
        • 一時停止
        • 19_TP Csorna_Trial Pharma LLC Csorna
      • Debrecen、ハンガリー、4031
        • 積極的、募集していない
        • 09_Derma-B Debrecen_DERMA-B LLC
      • Debrecen、ハンガリー、4032
        • 積極的、募集していない
        • 05_DE Debrecen_University of Debrecen Clinical Centre, Institute for Primary Care and Health Promotion of Debrecen
      • Encs、ハンガリー、3860
        • 募集
        • 36_CRU Encs_CRU Hungary Healthcare and Service Provider LLC.
        • コンタクト：
      • Gyula、ハンガリー、5700
        • 募集
        • 16_TP Gyula_Trial Pharma LLC Gyula
        • コンタクト：
      • Győr、ハンガリー、9026
        • 一時停止
        • 13_TP Győr_Trial Pharma LLC Győr
      • Hatvan、ハンガリー、3000
        • 募集
        • 34_BKS Hatvan_BKS Research Ltd. Albert Schweitzer Hospital and Outpatient Clinic
        • コンタクト：
      • Jászszentlászló、ハンガリー、6133
        • 募集
        • 33_TP Fitt Harmony_Fitt Harmony Ltd
        • コンタクト：
          • 33_TP Fitt Harmony
          • 電話番号：+36 20 404 6095
          • メール：info@h4h.hu
      • Kaposvár、ハンガリー、7400
        • 募集
        • 28_Kaposvár Kh_Somogy County Kaposi Mór Teaching Hospital
        • コンタクト：
          • 28_Kaposvár Kh
          • 電話番号：+36 82 501 300
          • メール：korhaz@kmmk.hu
      • Kecskemét、ハンガリー、6000
        • 募集
        • 30_TP Kék Pont Kecskemét_Blue Point Aquatherapy Ltd. (KomplexLabor site)
        • コンタクト：
      • Kecskemét、ハンガリー、6000
        • 募集
        • 39_TP Kecskemét_Trial Pharma Ltd. Kecskemét
        • コンタクト：
          • 39_TP Kecskemét
          • 電話番号：+36 20 404 6095
          • メール：info@h4h.hu
      • Miskolc、ハンガリー、3526
        • 募集
        • 26_BAZ Miskolc_Borsod-Abaúj-Zemplén County Central Hospital and University Teaching Hospital
        • コンタクト：
      • Nyíregyháza、ハンガリー、4400
        • 積極的、募集していない
        • 21_TP Nyíregyháza_Trial Pharma LLC Nyíregyháza
      • Orosháza、ハンガリー、5900
        • 積極的、募集していない
        • 15_TP Orosháza_Trial Pharma LLC Orosháza
      • Orosháza、ハンガリー、5900
        • 募集
        • 25_DermaMed_DermaMed Research LCC.
        • コンタクト：
      • Pécs、ハンガリー、7621
        • 募集
        • 38_Ganglion Orvosi Központ Nozologen Kft._Ganglion Medical Center
        • コンタクト：
          • 38_Ganglion Orvosi Központ Nozologen Kft
          • 電話番号：+36 30 539 2825
          • メール：info@ganglion.hu
      • Pécs、ハンガリー、7624
        • 積極的、募集していない
        • 02_PTE Pécs_University of Pécs, Centre for Occupational Health and Hygiene of the University of Pécs Clinical Centre
      • Sopron、ハンガリー、9400
        • 募集
        • 18_TP Sopron_Trial Pharma LLC Sopron
        • コンタクト：
          • 18_TP Sopron
          • 電話番号：+36 20 960 9400
          • メール：diag@newmed.hu
      • Szeged、ハンガリー、6724
        • 募集
        • 37_KomplexLabor_KomplexLabor Diagnostics Ltd.
        • コンタクト：
      • Szeged、ハンガリー、6726
        • 募集
        • 17_TP Szeged_Trial Pharma LLC Szeged
        • コンタクト：
      • Szeged、ハンガリー、6726
        • 募集
        • 24_MÁV_Szeged_Hungarian State Railways Clinic in Szeged
        • コンタクト：
          • 24_MÁV_Szeged
          • 電話番号：+36 62 548 055
          • メール：info@h4h.hu
      • Székesfehérvár、ハンガリー、8000
        • 募集
        • 03_VVM Veszprém_Vita Verum Medical LLP
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
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)

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Healthy aging
時間枠：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
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Molecular fingerprints
時間枠：10 years
Molecular fingerprints acquired from plasma samples.
10 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Center for Molecular Fingerprinting Research Nonprofit LLC

協力者

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

捜査官

  • 主任研究者：Ferenc Krausz, Prof, PhD、Center for Molecular Fingerprinting Research Nonprofit LLC
  • 主任研究者：Domokos Gerő, MD, PhD、Center for Molecular Fingerprinting Research Nonprofit LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2021年7月27日

一次修了 (推定)

2030年12月31日

研究の完了 (推定)

2030年12月31日

試験登録日

最初に提出

2026年7月29日

QC基準を満たした最初の提出物

2026年7月29日

最初の投稿 (実際)

2026年8月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月3日

QC基準を満たした最後の更新が送信されました

2026年7月29日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • H4H_HU_2020_Sample Collection

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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