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NCT Number: NCT07569094

Research Plan for Early Disease Screening Biomarkers in Healthy Individuals

The establishment of reference intervals for biomarkers in healthy populations relies on large-scale, standardized cohort data. However, current baseline data for hematology, liver and kidney function, and multi-omics (genomics, transcriptomics, proteomics, and metabolomics) in Chinese healthy populations are constrained by significant regional disparities and insufficient sample sizes, limiting the development of early disease screening markers. To address these challenges, this study aims to: (1) establish a comprehensive database for hematology and liver/kidney function indicators; (2) construct a multi-omics database using blood and sputum samples; and (3) explore the correlations among multi-omics indicators and their associations with demographic characteristics.

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Key information

Conditions

Health

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 - 65 years old, gender not restricted;
  • No clear history of chronic diseases (hypertension, diabetes, cardiovascular and cerebrovascular diseases, chronic liver and kidney diseases, tumors, etc.);
  • No infection history in the past 3 months (fever, cough, sore throat, etc.);
  • No use of antibiotics, hormones, immunosuppressants, etc. within the past 1 month;
  • Voluntarily sign the informed consent form and cooperate to complete the follow-up.

Exclusion criteria

  • Abnormal laboratory indicators (ALT/AST > 2 times the upper limit of normal value, Cr > upper limit of normal value, main indicators of blood routine test are abnormal and have clinical significance);
  • Pregnant or lactating women;
  • Recent (within 3 months) history of surgery, trauma or blood transfusion;
  • Mental illness or cognitive impairment that makes it impossible to cooperate with the research.

Treatment and study plan

Primary outcomes

  1. Blood routine test

    Time frame: At the time of enrollment

Secondary outcomes

  1. Liver function

    Time frame: At the time of enrollment

  2. renal function

    Time frame: At the time of enrollment

Other outcomes

  1. Transcriptomics

    Time frame: At the time of enrollment

  2. Proteomics

    Time frame: At the time of enrollment

  3. Metagenome

    Time frame: At the time of enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Peng, Doctor

CONTACT

[email protected]

86-020-85959142

Sponsors and collaborators

Lead sponsor

Zhonghao Fang

Other

Collaborators

  • Fifth Affiliated Hospital of Guangzhou Medical University

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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