Research Plan for Early Disease Screening Biomarkers in Healthy Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Health. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Blood routine test [Time frame: At the time of enrollment]
Secondary outcome measures (2)
- Liver function [Time frame: At the time of enrollment]
- renal function [Time frame: At the time of enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou
Identifiers
NCT: NCT07569094 · P-2026-002